Overview

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

Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
North Suffolk Mental Health Association
Collaborator:
RespireRx
Treatments:
Clozapine
Olanzapine
Risperidone