Optimizing Response in Psychosis Study
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder Not Otherwise Specified
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: long-acting injectable risperidone
Intervention description: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 15 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: first episode; schizophrenia; risperidone

Summary:

      The purpose of this project is to evaluate the efficacy of long-acting risperidone for
      patients with first episode schizophrenia spectrum who did not improve sufficiently with the
      first antipsychotic medication they tried during their initial treatment trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current DSM-IV-defined diagnosis of schizophrenia, schizophreniform disorder,
             schizoaffective disorder, or psychotic disorder NOS as assessed using the Structured
             Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1998)

          -  Is in the first episode of illness. First episode is defined as having had 6 months or
             less of lifetime treatment with an antipsychotic.

          -  Has not responded sufficiently to treatment with an antipsychotic. Lack of response is
             defined as a rating at study entry of 4 (moderate) or more on at least one of the
             following BPRS-A items: conceptual disorganization, grandiosity, hallucinatory
             behavior, unusual thought content.

          -  Continuous antipsychotic treatment at the time of study entry of a minimum of 12 weeks
             with the same antipsychotic agent.

          -  Antipsychotic dosing at some point during the 12 weeks must have reached a sufficient
             dose for antipsychotic response (e.g. patients who received only low dose quetiapine
             for insomnia or anxiety would not qualify). Sufficient dose for second generation
             antipsychotics is defined as a minimum dose of risperidone 3 mg/day, olanzapine 10
             mg/day, quetiapine 500 mg/day, ziprasidone 100 mg/day or aripiprazole 15 mg/day.
             Sufficient dose for first generation antipsychotics is defined as 3 mg/day of
             haloperidol or its equivalent for other first generation agents.

          -  Aged 15 to 40.

          -  If age 18 or older, competent and willing to sign informed consent.

          -  If under age 18, parent or guardian consent and subject assent.

          -  For women, a negative urine pregnancy test and agreement to use a medically accepted
             method of birth control.

        Exclusion criteria:

          -  Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic
             disorder due to a general medical condition, delusional disorder, brief psychotic
             disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar)
             with psychotic features.

          -  Persistence of psychotic symptoms due to nonadherence to antipsychotic medication.

          -  Medical contraindications to treatment with long-acting injectable risperidone.

          -  Serious neurological or endocrine disorder or medical condition /treatment known to
             affect the brain.

          -  A medical condition requiring medication with psychotropic effects.

          -  Clinical assessment that trial participation is contraindicated due to risk for
             homicidal or suicidal behavior.

          -  A diagnosis of diabetes (fasting glucose > 126 mg/dl).

          -  Requires with antidepressant or mood stabilizing medication.

          -  Previous treatment with a long acting formulation of an antipsychotic