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

This study has been completed.
Sponsor:
Collaborators:
Stanley Medical Research Institute
Donaghue Foundation
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00237848
First received: September 13, 2005
Last updated: June 15, 2012
Last verified: April 2008
  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-Blind
Primary Purpose: Treatment
Official Title: D-Serine Augmentation of Cognitive Retraining in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Yale University:

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

Locations
India
National Institute of Mental Health and Neurosciences
Bangalore, Karnataka, India, 560029
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Donaghue Foundation
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, 103T-363
Study First Received: September 13, 2005
Last Updated: June 15, 2012
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 April 17, 2014