An Integrated Program for the Treatment of First Episode of Psychosis

Schizophrenia is a major mental illness characterized by psychosis, negative symptoms (e.g.,
apathy, social withdrawal, anhedonia), and cognitive impairment. Depression and substance
abuse commonly co-occur. These individuals have impaired functioning in the areas of work,
school, parenting, self-care, independent living, interpersonal relationships, and leisure
time. Among adult psychiatric disorders, schizophrenia is the most disabling, and its
treatment accounts for a disproportionate share of mental health services.

This study is part of the National Institute of Mental Health's Recovery After an Initial
Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the
trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the
earliest stages of illness. This study, the RAISE Early Treatment Program (ETP), is one of
the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project.
ETP is being supported in whole or in part with Federal funds from the American Recovery and
Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health
and Human Services.

The ETP study aims to compare two early treatment interventions for adolescents and adults
experiencing a first episode of psychosis. The clinical centers have been randomly allocated
to offer one of the two treatment programs. Both treatment interventions are designed to
provide a person with treatment soon after he or she experiences the early signs of
schizophrenia. Participants will be offered mental health services such as medication and
psychosocial therapy. These strategies are all aimed at promoting symptom reduction and
improving life functioning. Participation in this study will last between 2 and 3 years. All
participants will first undergo an initial videoconference interview to confirm a diagnosis
of schizophrenia, schizoaffective disorder, psychosis NOS, brief psychotic disorder, or
schizophreniform disorder. Eligible participants will then be offered mental health services.

In addition to the mental health services, participants will participate in a series of
research interviews. Participants will be interviewed every 3 months for the first 6 months
and then every 6 months for up to 3 years. At the research visit, participants will complete
an interview about their symptoms and general quality of life, complete questions about
experiences with their illness, their vital signs will be measured, and a blood draw will be
collected. At the initial, 12 and 24 month visits, participants will also complete a brief
test that assesses skills such as memory, attention and problem solving. Participants will
also have monthly telephone interviews about their illness and services that they have
received.

Inclusion Criteria:

- Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of:

- schizophrenia, schizoaffective disorder, schizophreniform disorder, brief
psychotic disorder, psychotic disorder NOS

- Any duration of untreated psychosis

- Any ethnicity

- Ability to participate in research assessments in English

- Ability to provide fully informed consent (assent for those under age 18)

Exclusion Criteria:

- Inability to understand what research participation entails or correctly answer the
questions about research participation that are part of the Study Information Review
and provide fully informed consent

- More than 4 months of prior cumulative treatment with antipsychotic medications

- Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic
disorder

- Current psychotic disorder due to a general medical condition

- Current neurological disorders that would affect diagnosis or prognosis. These would
include, but are not limited to seizure disorders, dementing or degenerative
disorders, lesions or substantial congenital abnormalities. In most cases, disorders
such as headache disorders would not require protocol exclusion

- Clinically significant head trauma

- Any other serious medical condition that in the opinion of the investigator would
seriously impair functioning making the patient unsuitable for the trial