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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Donaghue Foundation; Stanley Medical Research Institute; US Department of Veterans Affairs; VA Office of Research and Development

Criteria

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