Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia
Completed · Phase 2/Phase 3
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT00235352
- Run by
- North Suffolk Mental Health Association
- People needed
- 105
- Starts
- 2002-02-01
- Expected to finish
- 2007-02-01
- Last updated by the study team
- 2009-02-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Schizophrenia, any subtype
- Ages 18-65 years
- Capable of providing informed consent
- Stable dose of clozapine, olanzapine or risperidone for at least 6 months
You may not qualify if…
- Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
- Current substance abuse
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- Unable to complete neuropsychological tests
- History of serious blood dyscrasia requiring discontinuation of clozapine
- Serious suicidal or homicidal risk within the past six months
Where it is running
- Freedom Trail Clinic — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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