Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

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.

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