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

North Suffolk Mental Health Association

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophrenia

Treatments: Drug: CX516 (Ampakine)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00235352

IR43 MH59450

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of Schizophrenia, any subtype
2. Ages 18-65 years
3. Capable of providing informed consent
4. Stable dose of clozapine, olanzapine or risperidone for at least 6 months

Exclusion criteria

1. Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
2. Current substance abuse
3. Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
4. Unable to complete neuropsychological tests
5. History of serious blood dyscrasia requiring discontinuation of clozapine
6. Serious suicidal or homicidal risk within the past six months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind