Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Sponsor

Janssen Scientific Affairs, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02600741

Collaborator

(none)

296

Enrollment

Locations

35.4

Actual Duration (Months)

8.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Other: Caregiver psycho-education and skills training 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

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

Study Type:

Observational

Actual Enrollment :

296 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 24, 2015

Actual Primary Completion Date :

Jul 5, 2018

Actual Study Completion Date :

Jul 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Caregiver psycho-education and skills training 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. Drug: Paliperidone palmitate Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician. Drug: Chlorpromazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Droperidol Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Fluphenazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Haloperidol Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Loxapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Perphenazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Pimozide Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Prochlorperazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Thiothixene Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Thioridazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Trifluoperazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Aripiprazole Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Asenapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Clozapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Iloperidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Olanzapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Paliperidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Quetiapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Risperidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Ziprasidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
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.	Other: Caregiver support available at the study site Caregivers will receive whatever caregiver support that is customarily available at the study site, if any. Drug: Paliperidone palmitate Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician. Drug: Chlorpromazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Droperidol Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Fluphenazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Haloperidol Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Loxapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Perphenazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Pimozide Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Prochlorperazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Thiothixene Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Thioridazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Trifluoperazine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Aripiprazole Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Asenapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Clozapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Iloperidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Olanzapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Paliperidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Quetiapine Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Risperidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. Drug: Ziprasidone Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Arm

Intervention/Treatment

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.

Other: Caregiver psycho-education and skills training

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.

Drug: Paliperidone palmitate

Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.

Drug: Chlorpromazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Droperidol

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Fluphenazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Haloperidol

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Loxapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Perphenazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Pimozide

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Prochlorperazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Thiothixene

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Thioridazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Trifluoperazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Aripiprazole

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Asenapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Clozapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Iloperidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Olanzapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Paliperidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Quetiapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Risperidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Ziprasidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

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.

Other: Caregiver support available at the study site

Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.

Drug: Paliperidone palmitate

Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.

Drug: Chlorpromazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Droperidol

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Fluphenazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Haloperidol

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Loxapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Perphenazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Pimozide

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Prochlorperazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Thiothixene

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Thioridazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Trifluoperazine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Aripiprazole

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Asenapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Clozapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Iloperidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Olanzapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Paliperidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Quetiapine

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Risperidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Drug: Ziprasidone

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Outcome Measures

Primary Outcome Measures

Number of Treatment Failures Over 12 Months [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.

Secondary Outcome Measures

Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12 [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).
Number of Treatment Failures in Patients Taking Oral Antipsychotics [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.
Number of Treatment Failures in Patients Taking Paliperidone Palmitate [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.
Patient Recovery Based on Total Illness Management and Recovery (IMR) Score [Month 6 and Month 12]
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.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12 [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).
Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

1. 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

Contacts and Locations

Locations

	City	State	Country
1	Bullhead City	Arizona	United States
2	Oceanside	California	United States
3	Denver	Colorado	United States
4	Farmington	Connecticut	United States
5	Lauderdale Lakes	Florida	United States
6	Leesburg	Florida	United States
7	Miami	Florida	United States
8	Orange City	Florida	United States
9	Tallahassee	Florida	United States
10	West Palm Beach	Florida	United States
11	Atlanta	Georgia	United States
12	Granite City	Illinois	United States
13	Lombard	Illinois	United States
14	Springfield	Illinois	United States
15	Bloomington	Indiana	United States
16	Lawrenceburg	Indiana	United States
17	Ann Arbor	Michigan	United States
18	Grand Rapids	Michigan	United States
19	Mount Pleasant	Michigan	United States
20	Kansas City	Missouri	United States
21	Saint Louis	Missouri	United States
22	New York	New York	United States
23	Staten Island	New York	United States
24	Toledo	Ohio	United States
25	Oklahoma City	Oklahoma	United States
26	Eugene	Oregon	United States
27	Lincoln	Rhode Island	United States
28	Nashville	Tennessee	United States
29	Austin	Texas	United States
30	Fort Worth	Texas	United States
31	San Antonio	Texas	United States
32	Salt Lake City	Utah	United States
33	Richland	Washington	United States
34	Spokane	Washington	United States