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

Sponsored by:	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

MedlinePlus related topics: Schizophrenia

Drug Information available for: Serine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	D-Serine Augmentation of Cognitive Retraining in Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

PANSS
WCST
Hopkins Verbal Learning Test
Spatial working memory task

Secondary Outcome Measures:

Heinrichs-Carpenter Quality of Life Scale
Neurocognitive training tasks
Functional assessments

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, M.D.

203-932-5711 ext 4249

richa.yadava@yale.edu

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

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.

Study ID Numbers:	RPA/020/03, 103T-363
Study First Received:	September 13, 2005
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00237848
Health Authority:	India: Ministry of Health; United States: Federal Government

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009