Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) (FIRST)

January 21, 2019 updated by: Janssen Scientific Affairs, LLC

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Bullhead City, Arizona, United States
- California
  - Oceanside, California, United States
- Colorado
  - Denver, Colorado, United States
- Connecticut
  - Farmington, Connecticut, United States
- Florida
  - Lauderdale Lakes, Florida, United States
  - Leesburg, Florida, United States
  - Miami, Florida, United States
  - Orange City, Florida, United States
  - Tallahassee, Florida, United States
  - West Palm Beach, Florida, United States
- Georgia
  - Atlanta, Georgia, United States
- Illinois
  - Granite City, Illinois, United States
  - Lombard, Illinois, United States
  - Springfield, Illinois, United States
- Indiana
  - Bloomington, Indiana, United States
  - Lawrenceburg, Indiana, United States
- Michigan
  - Ann Arbor, Michigan, United States
  - Grand Rapids, Michigan, United States
  - Mount Pleasant, Michigan, United States
- Missouri
  - Kansas City, Missouri, United States
  - Saint Louis, Missouri, United States
- New York
  - New York, New York, United States
  - Staten Island, New York, United States
- Ohio
  - Toledo, Ohio, United States
- Oklahoma
  - Oklahoma City, Oklahoma, United States
- Oregon
  - Eugene, Oregon, United States
- Rhode Island
  - Lincoln, Rhode Island, United States
- Tennessee
  - Nashville, Tennessee, United States
- Texas
  - Austin, Texas, United States
  - Fort Worth, Texas, United States
  - San Antonio, Texas, United States
- Utah
  - Salt Lake City, Utah, United States
- Washington
  - Richland, Washington, United States
  - Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	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.	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. Other: Caregiver support available at the study site Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.

Group / Cohort

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