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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Donaghue Medical Research Foundation
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00237809
First received: September 13, 2005
Last updated: August 30, 2010
Last verified: August 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Serine
U.S. FDA Resources

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: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
D-serine/control
 Drug: D-serine
D-serine (30 mg/kg)
Experimental: 2
D-serine/cog rehab
 Drug: D-serine
D-serine (30 mg/kg)
Experimental: 3
Placebo/control
 Behavioral: Cognitive retraining
Cog rehab
Experimental: 4
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

Exclusion

  • Pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237809

Contacts
Contact: Rajiv Radhakrishnan, MD 203-932-5711 ext 3921 rajiv.radhakrishnan@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Completed
New Haven, Connecticut, United States, 06508
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Rajiv Radhakrishnan, MD     203-932-5711 ext 3921     rajiv.radhakrishnan@yale.edu    
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Deepak C D'Souza, M.D. Yale University
  More Information

Publications:

Responsible Party: Deepak Cyril D'Souza, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00237809     History of Changes
Other Study ID Numbers: 23594, DF01-015
Study First Received: September 13, 2005
Last Updated: August 30, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013