NCT02600741

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 296 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-07-24
• Primary completion: 2018-07-05
• Completion: 2018-07-05
• First posted: 2015-11-09
• Last updated: 2019-01-23

Locations

34 sites across 1 country: United States