Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia (CX516)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Placebo-Controlled Trial of CX516 (Ampakine) Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia|
- 1. Evaluate the effects of a four-week trial of CX516 900 mg tid compared to placebo upon verbal memory and attention (DCPT, CVLT, Letter-number sequencing) assessed as part of a standard cognitive battery.
- 2. Evaluate the effects of CX516 compared to placebo on negative symptoms measured by the SANS total score.
- 3. Evaluate tolerability and adverse effects measured by the AIMS and SAFTEE Scales.
- 4. Evaluate persistence and/or strengthening of effects 4 weeks after completion of the 4-week trial.
|Study Start Date:||February 2002|
|Study Completion Date:||February 2007|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
|United States, Massachusetts|
|Freedom Trail Clinic|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Donald C Goff, MD||North Suffolk Mental Health Association|