Trial | NCT00235352  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ampakine ...

  • Study Participants

    105
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.
Study Started
Feb 28
2002
Primary Completion
Apr 30
2005
Study Completion
Feb 28
2007
Last Update
Feb 26
2009
Estimate

Drug CX516 (Ampakine)

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted