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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237848
First Posted: October 12, 2005
Last Update Posted: June 18, 2012
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.
Collaborators:
Stanley Medical Research Institute
Donaghue Foundation
VA Office of Research and Development
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: D-Serine Augmentation of Cognitive Retraining in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Deepak C. D'Souza, Yale University:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS)
  • Wisconsin Card Sorting Test (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00237848


Locations
India
National Institute of Mental Health and Neurosciences
Bangalore, Karnataka, India, 560029
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Donaghue Foundation
VA Office of Research and Development
Investigators
Principal Investigator: Deepak C. D'Souza, MD Yale University
  More Information

Publications:
Responsible Party: Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00237848     History of Changes
Other Study ID Numbers: RPA/020/03
1R01DA022495 ( U.S. NIH Grant/Contract )
103T-363
First Submitted: September 13, 2005
First Posted: October 12, 2005
Last Update Posted: June 18, 2012
Last Verified: April 2008

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders