SchizophreniaPhase 3ARRIVE- EUNCT01509053
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
A Phase 3 study testing Aripiprazole (Abilify®) IM Depot Injection and Oral aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 10 sites in 3 countries.
Trial summary
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole (Abilify®) IM Depot Injection and Oral aripiprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2012to Oct 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to any protocol-required procedure.
- Male and female subjects 18 to 65 years of age, inclusive
- Current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and a history of the illness for at least 1 year (12 months)
- Subjects who in the investigator's judgment would benefit from extended treatment with a long-acting injectable formulation
- Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior entering the study
- Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase Subjects who have shown response to previous antipsychotic treatment.
- Subjects who understand the nature of the trial and are able to follow the protocol requirements.
Who cannot join
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial.
- Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial.
- Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication.
- Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
- Subjects with a history of hypersensitivity to antipsychotic agents.
- Subjects deemed intolerant of receiving injectable treatment.
Show all 20Show fewer
- Subjects who have received electroconvulsive therapy within the last 7 months prior to screening.
- Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
- Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- Subjects requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the Informed Consent Form (ICF) or during the screening period.
- Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 months) prior to screening.
- Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening.
- Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine.
- Treatment with long-acting injectable antipsychotics in which the last dose was within 7 months prior to screening.
- Subjects who have not been treated with oral antipsychotics for 7 months prior to screening.
- Subjects who have a significant risk of committing suicide
- Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
- Sexually active males and females who will not commit to utilizing birth control during the trial and for up to 180 days following the trial.
- Abnormal laboratory or physical examination results indicating a condition which may interfere with the results of the study or pose a safety risk to the subject.
- Subjects who have previously enrolled in an aripiprazole IM depot clinical study or who have participated in any clinical trial with an investigational agent within the past 30 days.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Belgium4 sites
Study site
Bruges, 8310
Study site
Brussels, 1160
Study site
Kortenberg, 3070
Study site
Liège, 4000
Bulgaria4 sites
Study site
Lovech, 5500
Study site
Novi Iskar, 1282
Study site
Pazardzhik, 4400
Study site
Tzerova Koria, 5047
Canada2 sites
Study site
Chatham, Ontario, N7M 5L9
Study site
Penticton, British Columbia, V2A 4M4
About this study
Official title: Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting, Europe, Canada and Asia
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
Read the detailed description
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole (Abilify®) IM Depot Injection, Oral aripiprazole
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole (Abilify®) IM Depot InjectionDrug
Also called ABILIFY®
400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.
Number of injections: 6. Participants have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2014.
Oral aripiprazoleDrug
Oral aripiprazole tablets 10-15 mg/day (up to 30 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole IM depot injection | Experimental | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary. Receives: Drug: Aripiprazole (Abilify®) IM Depot Injection; Drug: Oral aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Inpatient Psychiatric Hospitalization Rates
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.
Measured: Retrospective period Months 4-6; Prospective period Months 4-6
Secondary outcomes (4)
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.
Measured: Baseline, Week 24
Change From Baseline in PANSS Positive and Negative Subscale Scores
The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.
Measured: Baseline, Week 24
Clinical Global Impression of Severity (CGI-S) Score
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients.
Measured: Baseline, Week 24
Clinical Global Impression of Improvement (CGI-I) Score
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Peters-Strickland, Study director, Otsuka Pharmaceutical Development & Commercialization, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509053
- Sponsor's protocol ID
- 31-11-284
- Acronym
- ARRIVE- EU
- Status last verified
- Feb 2015
- First submitted
- 13 Dec 2011
- Last updated
- 4 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting, Europe, Canada and Asia
- ClinicalTrials.gov ID
- NCT01509053
- Acronym / sponsor ID
- ARRIVE- EU / 31-11-284
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Posted 16 Jan 2014
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 compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
Detailed description
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole IM depot injection | Experimental | Drug: Aripiprazole (Abilify®) IM Depot Injection, Drug: Oral aripiprazolePatients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to any protocol-required procedure.
- Male and female subjects 18 to 65 years of age, inclusive
- Current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and a history of the illness for at least 1 year (12 months)
- Subjects who in the investigator's judgment would benefit from extended treatment with a long-acting injectable formulation
- Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior entering the study
Key exclusion criteria (20 listed)
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial.
- Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial.
- Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication.
- Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
- Subjects with a history of hypersensitivity to antipsychotic agents.
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 |
|---|---|---|
| Aripiprazole (Abilify®) IM Depot InjectionAlso: ABILIFY®400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg. Number of injections: 6. Participants have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2014. | Drug | Aripiprazole IM depot injection |
| Oral aripiprazoleOral aripiprazole tablets 10-15 mg/day (up to 30 mg/day). | Drug | Aripiprazole IM depot injection |
Primary outcome
Comparison of Inpatient Psychiatric Hospitalization Rates
Time frame: Retrospective period Months 4-6; Prospective period Months 4-6
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.
4 secondary outcomes
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline, Week 24
Change From Baseline in PANSS Positive and Negative Subscale Scores
Time frame: Baseline, Week 24
Clinical Global Impression of Severity (CGI-S) Score
Time frame: Baseline, Week 24
Clinical Global Impression of Improvement (CGI-I) Score
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tim Peters-Strickland study director
Otsuka Pharmaceutical Development & Commercialization, Inc.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole (Abilify®) IM Depot Injection and Oral aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. 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: stopped early, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Bulgaria, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Inpatient Psychiatric Hospitalization Rates (time frame: Retrospective period Months 4-6; Prospective period Months 4-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2015.