Optimizing Response in Psychosis Study

NCT00314327 | Terminated Phase 4 Results DMC

• 1 other identifier: 05.04.161
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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 medication they tried during their initial treatment trial.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder Not Otherwise Specified

Keywords

first episode; schizophrenia; risperidone

Outcome Measures

Primary Outcomes (1)

• Treatment Response Based Upon BPRS and CGI Ratings

  13 weeks

Secondary Outcomes (1)

• Negative Symptoms

  13 weeks

Study Arms (1)

long-acting injectable risperidone

EXPERIMENTAL

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.

Drug: long-acting injectable risperidone

Interventions

long-acting injectable risperidone DRUG

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.

Also known as: Risperdal (oral) & Risperdal Consta

long-acting injectable risperidone

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• The Zucker Hillside Hospital: collaborator
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (2)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Related Links

• web site of NARSAD

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Delbert Robinson, M.D.
• Organization: NSLIJ

Drobinson@nshs.edu

718-470-8195

Study Officials

• Delbert G Robinson, M.D.

  The North Shore-Long Island Jewish Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 13, 2006
• Study Start: April 1, 2006
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 16, 2018
• Results First Posted: April 29, 2015

Record last verified: 2018-04

Locations

US (2)