NCT00235352

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

A Placebo-Controlled Trial of CX516 (Ampakine) Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: North Suffolk Mental Health Association · Academic / Other
• Sex: —
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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

• Schizophrenia

Interventions

Type	Name	Description
DRUG	CX516 (Ampakine)

Timeline

• Start date: 2002-02-01
• Primary completion: 2005-04-01
• Completion: 2007-02-01
• First posted: 2005-10-10
• Last updated: 2009-02-26

Locations

1 site across 1 country: United States