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

Sponsors and Collaborators:	Yale University 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

MedlinePlus related topics: Schizophrenia

Drug Information available for: Serine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

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:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental D-serine/control	Drug: D-serine D-serine
2: Experimental D-serine/cog rehab	Drug: D-serine D-serine
3: Experimental Placebo/control	Behavioral: Cognitive retraining Cog rehab
4: Experimental 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
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: NCT00237809

Contacts

Contact: Savita Bhakta, M.D.

203-932-5711 ext 2525

savita.bhakta@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Richa Yadava, M.D. 203-932-5711 ext 4249 richa.yadava@yale.edu
Connecticut Mental Health Center	Recruiting
New Haven, Connecticut, United States, 06508
Contact: Kimberlee A Forselius-Bielen 203-974-7540 kimberlee.forselius@yale.edu

Sponsors and Collaborators

Yale University

National Alliance for Research on Schizophrenia and Depression

Donaghue Medical Research Foundation

Investigators

Principal Investigator:

Edward B Perry, 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:	Yale University School of Medicine ( Edward Perry, M.D. )
Study ID Numbers:	23594, DF01-015
Study First Received:	September 13, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00237809
Health Authority:	United States: Institutional Review Board

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 16, 2009