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Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia

NCT00235352 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2009-02-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects of a four-week trial of CX516 900mg tid compared to placebo upon verbal memory, attention and negative symptoms. The AMPA receptor positive modulator, CX516, will be added to a stable dose of clozapine, olanzapine or risperidone in inpatients and outpatients with schizophrenia. The trial is intended to extend and replicate results from our previous placebo-controlled pilot trial of CX516 added to clozapine in which the investigators found improvement in memory and attention (moderate-to-large between group effect sizes) and did not observe serious side effects. Because the investigators' pilot trial also detected at two-week follow-up persistence of cognitive benefits and emergence of a large therapeutic effect upon negative symptoms, this trial will also repeat clinical and cognitive assessments at follow-up, four weeks after completion of the study medication to evaluate persistence and/or strengthening of effects.

Conditions

Interventions

DRUG

CX516 (Ampakine)

Sponsors & Collaborators

  • RespireRx

    collaborator INDUSTRY

  • North Suffolk Mental Health Association

    lead OTHER

Principal Investigators

  • Donald C Goff, MD · North Suffolk Mental Health Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2005-04-30
Completion
2007-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00235352 on ClinicalTrials.gov