SchizophreniaFIRSTNCT02600741
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
An observational study of Schizophrenia, run by Janssen Scientific Affairs, LLC at 34 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Caregiver psycho-education and skills training, Caregiver support available at the study site and Paliperidone palmitate
- Type of treatment
- Pill or oral medicine
- How many people
- 296 participants
- Where
- 34 sitesUnited States
- Study dates
- 24 Jul 2015to 5 Jul 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will consist of a paired patient and caregiver. A caregiver is defined as a person who has accepted responsibility for providing the patient with both assistance with activities of daily living and protection from harm. The patient will have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Who may be able to join
- Caregivers
- Each caregiver must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate for the duration of the study
- Caregiver is able to have verbal interaction with the patient with schizophrenia, schizoaffective disorder, or schizophreniform disorder at least twice a week, per self-report
- Patients
- Patients must have a clinical diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria for these disorders
- Patients must be receiving ongoing psychiatric treatment at the study site and must be receiving oral antipsychotics or paliperidone palmitate long acting therapy
Who cannot join
- A) Caregivers
- Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by the treatment team
- Caregiver has received structured or manualized psycho-education or skills training within 1 year prior to Screening B) Patients
- Patient is hospitalized (medical or psychiatric), incarcerated, or otherwise institutionalized at time of randomization
- Patient is considered to have significant potential for imminent harm to self and/or others as based on the judgment of the treatment team
- Patient is receiving assertive community treatment (ACT) or other high intensity case management services to prevent hospitalization
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Bloomington, Indiana
Study site
Bullhead City, Arizona
Study site
Denver, Colorado
Study site
Eugene, Oregon
Study site
Farmington, Connecticut
Study site
Fort Worth, Texas
Study site
Grand Rapids, Michigan
Study site
Granite City, Illinois
Study site
Kansas City, Missouri
Study site
Lauderdale Lakes, Florida
Study site
Lawrenceburg, Indiana
Study site
Leesburg, Florida
Study site
Lincoln, Rhode Island
Study site
Lombard, Illinois
Study site
Miami, Florida
Study site
Mount Pleasant, Michigan
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Oceanside, California
Study site
Oklahoma City, Oklahoma
Study site
Orange City, Florida
Study site
Richland, Washington
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Spokane, Washington
Study site
Springfield, Illinois
Study site
St Louis, Missouri
Study site
Staten Island, New York
Study site
Tallahassee, Florida
Study site
Toledo, Ohio
Study site
West Palm Beach, Florida
About this study
Official title: A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic Treatment
The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.
Read the detailed description
This is a randomized, open-label, parallel group study of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder and their caregivers. Study will consist of a paired patient and caregiver. Patients will receive routine treatment, which may include oral antipsychotics or paliperidone palmitate, as directed by their treating physician. Caregivers for patients whose routine treatment is paliperidone palmitate will be randomized to receive either a study-provided caregiver psycho-education and skills training or usual caregiver support. Caregivers for patients whose routine treatment is oral antipsychotics will be randomized to the same Study Groups: Study Group 1: Study-provided caregiver psycho-education and skills training. Study Group 2: Usual caregiver support (caregiver support that is customarily provided by the study site, if any). Patients-caregiver pairs will be followed for up to 12 months following baseline assessment. Cumulative number of treatment failures over 12 months will be assessed primarily.
- Conditions
- Schizophrenia
- Being tested
- Caregiver psycho-education and skills training, Caregiver support available at the study site, Paliperidone palmitate, Chlorpromazine, Droperidol
- Keywords
- Schizophrenia, Caregiver, Psycho-education and skills training, Paliperidone Palmitate, Oral Antipsychotic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver psycho-education and skills trainingOther
Caregivers will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period.
Caregiver support available at the study siteOther
Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.
Paliperidone palmitateDrug
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
ChlorpromazineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DroperidolDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
FluphenazineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
HaloperidolDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
LoxapineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
PerphenazineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
PimozideDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
ProchlorperazineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
ThiothixeneDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
ThioridazineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
TrifluoperazineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
AripiprazoleDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
AsenapineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
ClozapineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
IloperidoneDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
OlanzapineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
PaliperidoneDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
QuetiapineDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
RisperidoneDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
ZiprasidoneDrug
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Caregivers randomized to this group will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician. Receives: Other: Caregiver psycho-education and skills training; Drug: Paliperidone palmitate; Drug: Chlorpromazine; Drug: Droperidol; Drug: Fluphenazine; Drug: Haloperidol; Drug: Loxapine; Drug: Perphenazine; Drug: Pimozide; Drug: Prochlorperazine; Drug: Thiothixene; Drug: Thioridazine; Drug: Trifluoperazine; Drug: Aripiprazole; Drug: Asenapine; Drug: Clozapine; Drug: Iloperidone; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone; Drug: Ziprasidone | |
| Study group 2 | Caregivers randomized to this group will receive whatever caregiver support that is customarily available at the study site, if any. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician. Receives: Other: Caregiver support available at the study site; Drug: Paliperidone palmitate; Drug: Chlorpromazine; Drug: Droperidol; Drug: Fluphenazine; Drug: Haloperidol; Drug: Loxapine; Drug: Perphenazine; Drug: Pimozide; Drug: Prochlorperazine; Drug: Thiothixene; Drug: Thioridazine; Drug: Trifluoperazine; Drug: Aripiprazole; Drug: Asenapine; Drug: Clozapine; Drug: Iloperidone; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone; Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Failures Over 12 Months
Treatment failure is defined as any of the following:
- Psychiatric hospitalization
- Psychiatric emergency room (ER) visit
- Crisis center visit
- Mobile crisis unit intervention
- Arrest/Incarceration
- Suicide or suicide attempt.
Measured: 12 months
Secondary outcomes (6)
Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12
The IEQ is designed to measure levels of caregiver consequences among family members and friends of patients with schizophrenia. The 31 items included in this scale are answered on a 5 point Likert response scale and address consequences among 4 dimensions (tension, supervision, worrying, and urging).
Measured: Month 12
Number of Treatment Failures in Patients Taking Oral Antipsychotics
Treatment failure is defined as any of the following:
- Psychiatric hospitalization
- Psychiatric emergency room (ER) visit
- Crisis center visit
- Mobile crisis unit intervention
- Arrest/Incarceration
- Suicide or suicide attempt.
Measured: 12 months
Number of Treatment Failures in Patients Taking Paliperidone Palmitate
Treatment failure is defined as any of the following:
- Psychiatric hospitalization
- Psychiatric emergency room (ER) visit
- Crisis center visit
- Mobile crisis unit intervention
- Arrest/Incarceration
- Suicide or suicide attempt.
Measured: 12 months
Patient Recovery Based on Total Illness Management and Recovery (IMR) Score
The IMR program was developed in order to help patients with schizophrenia or major mood disorders learn how to manage their illnesses more effectively in the context of pursuing their personal goals.
Measured: Month 6 and Month 12
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12
The CGI-S rating scale is used to rate the severity of a patient's overall clinical condition on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) to 7 (amongst the most severely ill patients).
Measured: Month 12
Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12
The 12-item Short Form Health Survey (SF-12) is a self-administered, generic, 12-item questionnaire designed to cover the same 8 domains of functional health status and well-being included in the longer 36-item Short Form Health Survey (SF 36): physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start24 Jul 2015
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study chair, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600741
- Sponsor's protocol ID
- CR106399
- Other IDs
- R092670SCH4043
- Acronym
- FIRST
- Status last verified
- Jan 2019
- First submitted
- 29 Sep 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mueser KT, Achtyes ED, Gogate J, Mancevski B, Kim E, Starr HL. Telehealth-Based Psychoeducation for Caregivers: The Family Intervention in Recent-Onset Schizophrenia Treatment Study. JMIR Ment Health. 2022 Apr 15;9(4):e32492. doi: 10.2196/32492.
PubMed 35436231
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic Treatment
- ClinicalTrials.gov ID
- NCT02600741
- Acronym / sponsor ID
- FIRST / CR106399
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Caregiver, Psycho-education and skills training, Paliperidone Palmitate, Oral Antipsychotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2015 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 9 Nov 2015 (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 primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.
Detailed description
This is a randomized, open-label, parallel group study of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder and their caregivers. Study will consist of a paired patient and caregiver. Patients will receive routine treatment, which may include oral antipsychotics or paliperidone palmitate, as directed by their treating physician. Caregivers for patients whose routine treatment is paliperidone palmitate will be randomized to receive either a study-provided caregiver psycho-education and skills training or usual caregiver support. Caregivers for patients whose routine treatment is oral antipsychotics will be randomized to the same Study Groups: Study Group 1: Study-provided caregiver psycho-education and skills training. Study Group 2: Usual caregiver support (caregiver support that is customarily provided by the study site, if any). Patients-caregiver pairs will be followed for up to 12 months following baseline assessment. Cumulative number of treatment failures over 12 months will be assessed primarily.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | Other: Caregiver psycho-education and skills training, Drug: Paliperidone palmitate, Drug: Chlorpromazine, Drug: Droperidol, Drug: Fluphenazine, Drug: Haloperidol, Drug: Loxapine, Drug: Perphenazine, Drug: Pimozide, Drug: Prochlorperazine, Drug: Thiothixene, Drug: Thioridazine, Drug: Trifluoperazine, Drug: Aripiprazole, Drug: Asenapine, Drug: Clozapine, Drug: Iloperidone, Drug: Olanzapine, Drug: Paliperidone, Drug: Quetiapine, Drug: Risperidone, Drug: ZiprasidoneCaregivers randomized to this group will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician. |
| Study group 2 | – | Other: Caregiver support available at the study site, Drug: Paliperidone palmitate, Drug: Chlorpromazine, Drug: Droperidol, Drug: Fluphenazine, Drug: Haloperidol, Drug: Loxapine, Drug: Perphenazine, Drug: Pimozide, Drug: Prochlorperazine, Drug: Thiothixene, Drug: Thioridazine, Drug: Trifluoperazine, Drug: Aripiprazole, Drug: Asenapine, Drug: Clozapine, Drug: Iloperidone, Drug: Olanzapine, Drug: Paliperidone, Drug: Quetiapine, Drug: Risperidone, Drug: ZiprasidoneCaregivers randomized to this group will receive whatever caregiver support that is customarily available at the study site, if any. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist of a paired patient and caregiver. A caregiver is defined as a person who has accepted responsibility for providing the patient with both assistance with activities of daily living and protection from harm. The patient will have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Key inclusion criteria (6 listed)
- Caregivers
- Each caregiver must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate for the duration of the study
- Caregiver is able to have verbal interaction with the patient with schizophrenia, schizoaffective disorder, or schizophreniform disorder at least twice a week, per self-report
- Patients
- Patients must have a clinical diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria for these disorders
Key exclusion criteria (6 listed)
- A) Caregivers
- Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by the treatment team
- Caregiver has received structured or manualized psycho-education or skills training within 1 year prior to Screening B) Patients
- Patient is hospitalized (medical or psychiatric), incarcerated, or otherwise institutionalized at time of randomization
- Patient is considered to have significant potential for imminent harm to self and/or others as based on the judgment of the treatment team
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 |
|---|---|---|
| Caregiver psycho-education and skills trainingCaregivers will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period. | Other | Study group 1 |
| Caregiver support available at the study siteCaregivers will receive whatever caregiver support that is customarily available at the study site, if any. | Other | Study group 2 |
| Paliperidone palmitatePatients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| ChlorpromazinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| DroperidolPatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| FluphenazinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| HaloperidolPatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| LoxapinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| PerphenazinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| PimozidePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| ProchlorperazinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| ThiothixenePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| ThioridazinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| TrifluoperazinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| AripiprazolePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| AsenapinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| ClozapinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| IloperidonePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| OlanzapinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| PaliperidonePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| QuetiapinePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| RisperidonePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
| ZiprasidonePatients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. | Drug | Study group 1, Study group 2 |
Primary outcome
Number of Treatment Failures Over 12 Months
Time frame: 12 months
Treatment failure is defined as any of the following: 1. Psychiatric hospitalization 2. Psychiatric emergency room (ER) visit 3. Crisis center visit 4. Mobile crisis unit intervention 5. Arrest/Incarceration 6. Suicide or suicide attempt.
6 secondary outcomes
Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12
Time frame: Month 12
Number of Treatment Failures in Patients Taking Oral Antipsychotics
Time frame: 12 months
Number of Treatment Failures in Patients Taking Paliperidone Palmitate
Time frame: 12 months
Patient Recovery Based on Total Illness Management and Recovery (IMR) Score
Time frame: Month 6 and Month 12
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12
Time frame: Month 12
Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12
Time frame: Month 12
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 23 Jan 2019.
- Derived from this study: PubMed 35436231Mueser KT, Achtyes ED, Gogate J, Mancevski B, Kim E, Starr HL. Telehealth-Based Psychoeducation for Caregivers: The Family Intervention in Recent-Onset Schizophrenia Treatment Study. JMIR Ment Health. 2022 Apr 15;9(4):e32492. doi: 10.2196/32492.
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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 Scientific Affairs, LLC Clinical Trial study chair
Janssen Scientific Affairs, LLC
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen Scientific Affairs, LLC at 34 sites in United States.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. 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.
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?
Number of Treatment Failures Over 12 Months (time frame: 12 months). 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 NCT02600741, 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 23 Jan 2019.