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

NCT ID: NCT00237848

Last Updated: 2012-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28

Brief Summary

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

Detailed 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

D-serine

Intervention Type: DRUG

Cognitive retraining

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Donaghue Foundation

UNKNOWN

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Deepak C. D'Souza

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepak C. D'Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, India

Countries

India

References

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. doi: 10.1176/ajp.156.11.1822.

Reference Type: BACKGROUND

PMID: 10553752 (View on PubMed)

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. doi: 10.1016/s0006-3223(98)00279-0.

Reference Type: BACKGROUND

PMID: 9836012 (View on PubMed)

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. doi: 10.1016/j.biopsych.2004.12.037.

Reference Type: BACKGROUND

PMID: 15780844 (View on PubMed)

Other Identifiers

1R01DA022495

Identifier Type: NIH

Identifier Source: secondary_id

View Link

103T-363

Identifier Type: -

Identifier Source: secondary_id

RPA/020/03

Identifier Type: -

Identifier Source: org_study_id