Optimizing Response in Psychosis Study

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborators: National Alliance for Research on Schizophrenia and Depression; The Zucker Hillside Hospital
• Treatments: Risperidone

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