D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00237848

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	D-Serine Augmentation of Cognitive Retraining 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 National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Positive and Negative Syndrome Scale (PANSS) [ Designated as safety issue: Yes ]
Wisconsin Card Sorting Test (WCST) [ Designated as safety issue: No ]
Hopkins Verbal Learning Test [ Designated as safety issue: No ]
Spatial working memory task [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	72
Study Start Date:	February 2005

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.

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237848

Contacts

Contact: Richa Yadava, MD

203-932-5711 ext 4249

richa.yadava@yale.edu

Locations

India
National Institute of Mental Health and Neurosciences	Recruiting
Bangalore, Karnataka, India, 560029
Contact: Chittaranjan Andrade, MD 91-80-6566814 andrade@nimhans.kar.nic.in

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Deepak C. D'Souza, MD

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 C. D'Souza , MD, Yale School of Medicine
ClinicalTrials.gov Identifier:	NCT00237848 History of Changes
Other Study ID Numbers:	RPA/020/03, 103T-363
Study First Received:	September 13, 2005
Last Updated:	October 5, 2010
Health Authority:	India: Ministry of Health; United States: Federal Government

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on February 13, 2012