D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia - Full Text View

Sponsor:	Yale University
Collaborators:	National Alliance for Research on Schizophrenia and Depression Donaghue Medical Research Foundation
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00237809

Purpose

This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: D-serine Behavioral: Cognitive retraining	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Serine

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

WCST [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Hopkins Verbal Learning Test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Spatial working memory task [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
PANSS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Heinrichs-Carpenter Quality of Life Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Neurocognitive training tasks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Functional assessments [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	September 2002
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 D-serine/control	Drug: D-serine D-serine (30 mg/kg)
Experimental: 2 D-serine/cog rehab	Drug: D-serine D-serine (30 mg/kg)
Experimental: 3 Placebo/control	Behavioral: Cognitive retraining Cog rehab
Experimental: 4 Placebo/cog rehab	Behavioral: Cognitive retraining Cog rehab

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

Pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237809

Contacts

Contact: Rajiv Radhakrishnan, MD

203-932-5711 ext 3921

rajiv.radhakrishnan@yale.edu

Locations

United States, Connecticut
Connecticut Mental Health Center	Completed
New Haven, Connecticut, United States, 06508
VA Connecticut Healthcare System	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Rajiv Radhakrishnan, MD 203-932-5711 ext 3921 rajiv.radhakrishnan@yale.edu

Sponsors and Collaborators

Yale University

National Alliance for Research on Schizophrenia and Depression

Donaghue Medical Research Foundation

Investigators

Principal Investigator:

Deepak C D'Souza, M.D.

Yale University

More Information

Publications:

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.

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.

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.

Responsible Party:	Deepak Cyril D'Souza, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier:	NCT00237809 History of Changes
Other Study ID Numbers:	23594, DF01-015
Study First Received:	September 13, 2005
Last Updated:	August 30, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012