SchizophreniaPhase 4NCT00378092
A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode
A Phase 4 study testing Oral risperidone and Risperidone Long-Acting Injection (RLAI) in people with Schizophrenia, run by Janssen Cilag N.V./S.A. at 1 site in South Africa.
Trial summary
The purpose of this study is to evaluate the outcome of medication discontinuation, the safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from… Read more about this study
- Who is it for?
- Ages 17 to 47 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oral risperidone and Risperidone Long-Acting Injection (RLAI)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2006to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 47 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria: - Participants who completed 24 months RIS-PSY-301 study - Surgically sterile female participants or practicing an effective method of birth control before entry and throughout the study; and must have shown a negative urine serum pregnancy test at baseline before study entry - Participants who have signed informed consent document Exclusion Criteria: - Participants requiring treatment with mood stabilizers or antidepressants at study entry - Participants with evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosed in the last month before entry - Participants with a history of severe drug allergy, drug hypersensitivity, or neuroleptic malignant (cancerous) syndrome - Participants with known hypersensitivity to risperidone - Participants with acute risk of suicide at study entry or a history of suicidal attempt(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of the Clinical Outcome Following Treatment Discontinuation After Remission in First-Episode Schizophrenia
The purpose of this study is to evaluate the outcome of medication discontinuation, the safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) during the study observation period of 36 months.
Read the detailed description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single-arm, single-center study to assess the consequences of treatment discontinuation and evaluate clinical response to re-initiation of risperidone in case of relapse. The study will consist of 2 periods: Period 1 and Period 2. Participants who were on RLAI for 24 months and in remission (when a medical problem gets better or goes away at least for a while) state will enter in Period 1. In Period 1: RLAI will be tapered and discontinued over a period of 6 weeks. Participants will be regularly and carefully followed-up until their first disease relapse or a maximum of 36 months. In case of relapse (i.e., participants experience the same or similar symptoms to those experienced at the time of study entry in the previous Study RIS-PSY-301), participants will be transferred from Period 1 to Period 2. In Period 2, participants will re-start medication with RLAI (25 milligram [mg], 37.5 mg, or 50 mg [maximum]) and simultaneously start on oral (taken by mouth) risperidone (1 mg, 2 mg, or 3 mg). Doses will be adjusted at Investigator's discretion. Oral Risperidone will only be given for the first 3 weeks until the RLAI injection becomes effective. RLAI injections will continue for up to a maximum of 24 months. Participants will be followed-up until a (new) relapse or the treatment stopped, during a maximum of 24 months. The total duration of the study will be 36 months and will include 16 visits. Assessments will be performed every 2 months in the first year and every 3 months during the following 24 months period. Time to relapse and rate of relapse will be measured as primary outcome for Period 1 and degree of clinical improvement will be measured by Positive And Negative Syndrome Scale (PANSS) total score for schizophrenia. Time to response after re-exposure to treatment with RLAI will be measured as primary outcome for Period 2. Participants' safety will be monitored throughout the study.
- Conditions
- Schizophrenia
- Being tested
- Oral risperidone, Risperidone Long-Acting Injection (RLAI)
- Keywords
- Schizophrenia, Risperidone, Risperdal consta
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral risperidoneDrug
Oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injection becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits.
Risperidone Long-Acting Injection (RLAI)Drug
Also called Risperdal consta
RLAI 25 mg to 50 mg will be administered, intramuscularly which will be tapered and discontinued over a period of up to 6 weeks.
Risperidone Long-Acting Injection (RLAI)Drug
Also called Risperdal consta
Participants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus for up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Risperidone Long-Acting Injection (RLAI) (Period 1) | Experimental | Participants will receive 25 milligram (mg) to 50 mg of RLAI intramuscularly (into the muscle) which will be tapered and discontinued over a period of up to 6 weeks. Participants will be followed-up until their first disease relapse or maximum of 36 months. Receives: Drug: Risperidone Long-Acting Injection (RLAI) |
| Oral risperidone and RLAI (Period 2) | Experimental | Participants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus (a muscle) for up to 24 months. Supplementation with oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injections becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits. Receives: Drug: Oral risperidone; Drug: Risperidone Long-Acting Injection (RLAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1)
Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in Positive and Negative Syndrome Scale (PANSS) total score ranging from 30 (absent) to 210 (extreme ill); Clinical Global Impression (CGI-C) score of 6 ('much worse'); deliberate self-injury (as per adverse event [AE] reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).
Measured: Month 36 or early withdrawal (EW)
Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1)
Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in PANSS total score ranging from 30 (absent) to 210 (extreme ill); CGI-C score of 6 ('much worse'); deliberate self-injury (as per AE reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).
Measured: Month 36 or EW
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2)
The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Measured: Baseline and Month 24 or EW
Time to Treatment Response After Re-Initiation of RLAI (Period 2)
Time to treatment response after re-initiation of RLAI will be the time that elapse between Baseline assessment of PANSS for Period 2 and fulfilment of the response which is defined as greater than or equal to 20 percent improvement in PANSS total score. PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Measured: Month 24 or EW
Secondary outcomes (20)
Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1)
The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Measured: Baseline and Month 36 or EW
Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2)
The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Measured: Baseline and Month 24 or EW
Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1)
The PANSS total score consists of the sum of all 30 PANSS items and score ranges from 30 to 210. Higher scores indicate worsening. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 856; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility (UH) or excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28.
Measured: Baseline and Month 36 or EW
Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, UH or excitement subscale and anxiety or depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity.
Measured: Baseline and Month 24 or EW
Number of Participants With Disease Remission Based on PANSS (Period 1)
A participants will be 'in remission' when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria.
Measured: Month 36 or EW
Number of Participants With Disease Remission Based on PANSS (Period 2)
A participants will be 'in remission' when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria.
Measured: Month 24 or EW
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1)
The CGI-S scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of '1=Normal, not at all ill' and a rating of '7=Among the most extremely ill participants'. Higher scores indicate worsening.
Measured: Baseline and Month 36 or EW
Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1)
The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened.
Measured: Month 36 or EW
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2)
The CGI-S scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of '1=Normal, not at all ill' and a rating of '7=Among the most extremely ill participants'. Higher scores indicate worsening.
Measured: Baseline and Month 24 or EW
Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2)
The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened.
Measured: Month 24 or EW
Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1)
The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology.
Measured: Baseline and Month 36 or EW
Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2)
The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology.
Measured: Baseline and Month 24 or EW
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1)
The SOFAS is a 100- point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individual's psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.
Measured: Baseline and Month 36 or EW
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2)
The SOFAS is a 100-point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individual's psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.
Measured: Baseline and Month 24 or EW
Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1)
The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participant's past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse.
Measured: Baseline and Month 36 or EW
Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1)
The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse .
Measured: Month 36 or EW
Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2)
The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participant's past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse.
Measured: Baseline and Month 24 or EW
Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2)
The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse .
Measured: Month 24 or EW
Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1)
The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 score ranges from 10=maximum impairment to 70=no impairment.
Measured: Baseline and Month 36 or EW
Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2)
The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 scores range from 10=maximum impairment to 70=no impairment.
Measured: Baseline and Month 24 or EW
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag N.V./S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Study director, Janssen Cilag N.V./S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378092
- Sponsor's protocol ID
- CR011992
- Other IDs
- RISSCH3024
- Status last verified
- May 2014
- First submitted
- 15 Sep 2006
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Emsley R, Oosthuizen PP, Koen L, Niehaus DJ, Martinez G. Symptom recurrence following intermittent treatment in first-episode schizophrenia successfully treated for 2 years: a 3-year open-label clinical study. J Clin Psychiatry. 2012 Apr;73(4):e541-7. doi: 10.4088/JCP.11m07138.
PubMed 22579160
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Clinical Outcome Following Treatment Discontinuation After Remission in First-Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT00378092
- Acronym / sponsor ID
- CR011992
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Risperidone, Risperdal consta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Janssen Cilag N.V./S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the outcome of medication discontinuation, the safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) during the study observation period of 36 months.
Detailed description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single-arm, single-center study to assess the consequences of treatment discontinuation and evaluate clinical response to re-initiation of risperidone in case of relapse. The study will consist of 2 periods: Period 1 and Period 2. Participants who were on RLAI for 24 months and in remission (when a medical problem gets better or goes away at least for a while) state will enter in Period 1. In Period 1: RLAI will be tapered and discontinued over a period of 6 weeks. Participants will be regularly and carefully followed-up until their first disease relapse or a maximum of 36 months. In case of relapse (i.e., participants experience the same or similar symptoms to those experienced at the time of study entry in the previous Study RIS-PSY-301), participants will be transferred from Period 1 to Period 2. In Period 2, participants will re-start medication with RLAI (25 milligram [mg], 37.5 mg, or 50 mg [maximum]) and simultaneously start on oral (taken by mouth) risperidone (1 mg, 2 mg, or 3 mg). Doses will be adjusted at Investigator's discretion. Oral Risperidone will only be given for the first 3 weeks until the RLAI injection becomes effective. RLAI injections will continue for up to a maximum of 24 months. Participants will be followed-up until a (new) relapse or the treatment stopped, during a maximum of 24 months. The total duration of the study will be 36 months and will include 16 visits. Assessments will be performed every 2 months in the first year and every 3 months during the following 24 months period. Time to relapse and rate of relapse will be measured as primary outcome for Period 1 and degree of clinical improvement will be measured by Positive And Negative Syndrome Scale (PANSS) total score for schizophrenia. Time to response after re-exposure to treatment with RLAI will be measured as primary outcome for Period 2. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone Long-Acting Injection (RLAI) (Period 1) | Experimental | Drug: Risperidone Long-Acting Injection (RLAI)Participants will receive 25 milligram (mg) to 50 mg of RLAI intramuscularly (into the muscle) which will be tapered and discontinued over a period of up to 6 weeks. Participants will be followed-up until their first disease relapse or maximum of 36 months. |
| Oral risperidone and RLAI (Period 2) | Experimental | Drug: Oral risperidone, Drug: Risperidone Long-Acting Injection (RLAI)Participants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus (a muscle) for up to 24 months. Supplementation with oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injections becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits. |
Who may qualify
- Ages
- 17 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral risperidoneOral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injection becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits. | Drug | Oral risperidone and RLAI (Period 2) |
| Risperidone Long-Acting Injection (RLAI)Also: Risperdal constaRLAI 25 mg to 50 mg will be administered, intramuscularly which will be tapered and discontinued over a period of up to 6 weeks. | Drug | Risperidone Long-Acting Injection (RLAI) (Period 1) |
| Risperidone Long-Acting Injection (RLAI)Also: Risperdal constaParticipants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus for up to 24 months. | Drug | Oral risperidone and RLAI (Period 2) |
Primary outcome
Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1)
Time frame: Month 36 or early withdrawal (EW)
Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in Positive and Negative Syndrome Scale (PANSS) total score ranging from 30 (absent) to 210 (extreme ill); Clinical Global Impression (CGI-C) score of 6 ('much worse'); deliberate self-injury (as per adverse event [AE] reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).
Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1)
Time frame: Month 36 or EW
Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in PANSS total score ranging from 30 (absent) to 210 (extreme ill); CGI-C score of 6 ('much worse'); deliberate self-injury (as per AE reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Time to Treatment Response After Re-Initiation of RLAI (Period 2)
Time frame: Month 24 or EW
Time to treatment response after re-initiation of RLAI will be the time that elapse between Baseline assessment of PANSS for Period 2 and fulfilment of the response which is defined as greater than or equal to 20 percent improvement in PANSS total score. PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
20 secondary outcomes
Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1)
Time frame: Baseline and Month 36 or EW
Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1)
Time frame: Baseline and Month 36 or EW
Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
Number of Participants With Disease Remission Based on PANSS (Period 1)
Time frame: Month 36 or EW
Number of Participants With Disease Remission Based on PANSS (Period 2)
Time frame: Month 24 or EW
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1)
Time frame: Baseline and Month 36 or EW
Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1)
Time frame: Month 36 or EW
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2)
Time frame: Month 24 or EW
Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1)
Time frame: Baseline and Month 36 or EW
Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1)
Time frame: Baseline and Month 36 or EW
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1)
Time frame: Baseline and Month 36 or EW
Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1)
Time frame: Month 36 or EW
Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2)
Time frame: Month 24 or EW
Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1)
Time frame: Baseline and Month 36 or EW
Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2)
Time frame: Baseline and Month 24 or EW
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 22579160Emsley R, Oosthuizen PP, Koen L, Niehaus DJ, Martinez G. Symptom recurrence following intermittent treatment in first-episode schizophrenia successfully treated for 2 years: a 3-year open-label clinical study. J Clin Psychiatry. 2012 Apr;73(4):e541-7. doi: 10.4088/JCP.11m07138.
- Follow up of Schizophrenic Patients Following Treatment Discontinuation After Remission From a First Psychotic EpisodeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag N.V./S.A., Belgium Clinical Trial study director
Janssen Cilag N.V./S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral risperidone and Risperidone Long-Acting Injection (RLAI) in people with Schizophrenia, run by Janssen Cilag N.V./S.A. at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1) (time frame: Month 36 or early withdrawal (EW)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.