Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

• Status: Completed
• Trial end date: 2018-07-05
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Treatments: Antipsychotic Agents; Aripiprazole; Asenapine; Chlorpromazine; Clozapine; Droperidol; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate; Haloperidol; Iloperidone; Loxapine; Olanzapine; Paliperidone Palmitate; Perphenazine; Pimozide; Prochlorperazine; Quetiapine Fumarate; Risperidone; Thioridazine; Thiothixene; Trifluoperazine; Ziprasidone

Criteria

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