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

North Suffolk Mental Health Association105 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

105

Conditions

Schizophrenia

Interventions

Eligibility

Min age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.