Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia
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.
Timeline
- Start
- 2002-02
- Primary completion
- 2005-04
- Completion
- 2007-02
Outcome
Missed primary endpoint
paper Patients treated with CX516 did not differ from placebo in change from baseline on the composite cognitive score PMID 17487227 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CX516 | Other / unclassified | 900 mg | — |