D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia

Study Overview
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Brief Summary
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This study will examine the effectiveness of D-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.

Detailed Description
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This study is based on the hypothesis that by increasing NMDA receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining. Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Official Title
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D-Serine Augmentation of Cognitive Retraining in Schizophrenia

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: D-serine
* Behavioral: Cognitive retraining


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Clinically stable Treated with antipsychotic medications for at least 6 months in the past, and on a stable dose of the same antipsychotic medication over the past month Not pregnant or lactating Exclusion Criteria: Other current or past DSM-IV Axis I diagnosis Calgary Depression scale score >10 or Simpson-Angus Rating Scale score > 20 Currently treated with clozapine, lamotrigine or carbamazepine, or defined as treatment refractory Substance abuse or dependence within the past 3 months, except for nicotine Wechsler Adult Intelligence Scale-Revised score < 70 Significant recent (within past 3 months) risk of committing suicide Abnormal thyroid function tests within the last 6 months Previous treatment with D-serine History of evidence of a medical or neurological condition that would expose the subject to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the trial Clinically significant abnormal laboratory test results at screening ECT treatment within the past two months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: D-serine|nan|
|Behavioral: Cognitive retraining|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) |  |  | 
| Wisconsin Card Sorting Test (WCST) |  |  | 
| Hopkins Verbal Learning Test |  |  | 
| Spatial working memory task |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heinrichs-Carpenter Quality of Life Scale |  |  | 
| Neurocognitive training tasks |  |  | 
| Functional assessments |  |  |