Status:
TERMINATED
Optimizing Response in Psychosis Study
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
The Zucker Hillside Hospital
National Alliance for Research on Schizophrenia and Depression
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
15-40 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic, risperidone, for the treatment of first e...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00314327
Start Date
April 1 2006
End Date
November 1 2013
Last Update
May 16 2018
Active Locations (2)
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1
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
2
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004