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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237848
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 18, 2012
Stanley Medical Research Institute
Donaghue Foundation
US Department of Veterans Affairs
VA Office of Research and Development
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: D-serine Behavioral: Cognitive retraining Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: D-Serine Augmentation of Cognitive Retraining in Schizophrenia
Study Start Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Serine

Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS)
  2. Wisconsin Card Sorting Test (WCST)
  3. Hopkins Verbal Learning Test
  4. Spatial working memory task

Secondary Outcome Measures :
  1. Heinrichs-Carpenter Quality of Life Scale
  2. Neurocognitive training tasks
  3. Functional assessments

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237848

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National Institute of Mental Health and Neurosciences
Bangalore, Karnataka, India, 560029
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Donaghue Foundation
US Department of Veterans Affairs
VA Office of Research and Development
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Principal Investigator: Deepak C. D'Souza, MD Yale University
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Responsible Party: Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University Identifier: NCT00237848    
Other Study ID Numbers: RPA/020/03
1R01DA022495 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: April 2008
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders