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

Schizophrenia Clinical Trial

Official title:

D-Serine Augmentation of Cognitive Retraining in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237848
• Other study ID #: RPA/020/03
• Secondary ID: 1R01DA022495103T
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 15, 2012
• Start date: February 2005

Study information

• Verified date: April 2008
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of HealthUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• D-serine

Behavioral:
• Cognitive retraining

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neurosciences	Bangalore	Karnataka

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	Donaghue Foundation, Stanley Medical Research Institute, VA Office of Research and Development

Country where clinical trial is conducted

India, 

References & Publications (3)

Heresco-Levy U, Javitt DC, Ebstein R, Vass A, Lichtenberg P, Bar G, Catinari S, Ermilov M. D-serine efficacy as add-on pharmacotherapy to risperidone and olanzapine for treatment-refractory schizophrenia. Biol Psychiatry. 2005 Mar 15;57(6):577-85. — View Citation

Tsai G, Yang P, Chung LC, Lange N, Coyle JT. D-serine added to antipsychotics for the treatment of schizophrenia. Biol Psychiatry. 1998 Dec 1;44(11):1081-9. — View Citation

Tsai GE, Yang P, Chung LC, Tsai IC, Tsai CW, Coyle JT. D-serine added to clozapine for the treatment of schizophrenia. Am J Psychiatry. 1999 Nov;156(11):1822-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)			Yes
Primary	Wisconsin Card Sorting Test (WCST)			No
Primary	Hopkins Verbal Learning Test			No
Primary	Spatial working memory task			No
Secondary	Heinrichs-Carpenter Quality of Life Scale			No
Secondary	Neurocognitive training tasks			No
Secondary	Functional assessments			No