Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Loxapine; Drug: Fluphenazine; Drug: Pimozide; Drug: Haloperidol; Drug: Droperidol; Drug: Asenapine; Drug: Paliperidone; Drug: Thiothixene; Drug: Thioridazine; Drug: Prochlorperazine; Drug: Aripiprazole; Drug: Iloperidone; Drug: Perphenazine; Drug: Trifluoperazine; Drug: Paliperidone palmitate; Other: Caregiver support available at the study site; Drug: Chlorpromazine; Drug: Risperidone; Drug: Clozapine; Other: Caregiver psycho-education and skills training; Drug: Quetiapine; Drug: Ziprasidone

Study type: Observational

Funder types: Industry

Identifiers

NCT02600741

R092670SCH4043 (Other Identifier)

CR106399

Details and patient eligibility

About

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.

Full 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.

Enrollment: 296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A) 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

B) 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

• 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 design

296 participants in 2 patient groups

Study group 1

Description:

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.

Treatment:

Drug: Trifluoperazine

Drug: Loxapine

Drug: Droperidol

Drug: Paliperidone palmitate

Drug: Thiothixene

Drug: Fluphenazine

Drug: Olanzapine

Drug: Risperidone

Drug: Quetiapine

Drug: Iloperidone

Drug: Asenapine

Drug: Chlorpromazine

Drug: Haloperidol

Other: Caregiver psycho-education and skills training

Drug: Clozapine

Drug: Ziprasidone

Drug: Pimozide

Drug: Thioridazine

Drug: Prochlorperazine

Drug: Paliperidone

Drug: Perphenazine

Drug: Aripiprazole

Study group 2

Description:

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.

Treatment:

Drug: Trifluoperazine

Drug: Loxapine

Other: Caregiver support available at the study site

Drug: Droperidol

Drug: Paliperidone palmitate

Drug: Thiothixene

Drug: Fluphenazine

Drug: Olanzapine

Drug: Risperidone

Drug: Quetiapine

Drug: Iloperidone

Drug: Asenapine

Drug: Chlorpromazine

Drug: Haloperidol

Drug: Clozapine

Drug: Ziprasidone

Drug: Pimozide

Drug: Thioridazine

Drug: Prochlorperazine

Drug: Paliperidone

Drug: Perphenazine

Drug: Aripiprazole