Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
National Alliance for Research on Schizophrenia and Depression
Donaghue Medical Research Foundation
Information provided by:
Yale University Identifier:
First received: September 13, 2005
Last updated: August 30, 2010
Last verified: August 2010

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
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:

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
Drug: D-serine
D-serine (30 mg/kg)
Experimental: 2
D-serine/cog rehab
Drug: D-serine
D-serine (30 mg/kg)
Experimental: 3
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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder


  • Pregnant or lactating
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00237809

Contact: Rajiv Radhakrishnan, MD 203-932-5711 ext 3921

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   
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
Donaghue Medical Research Foundation
Principal Investigator: Deepak C D'Souza, M.D. Yale University
  More Information

Responsible Party: Deepak Cyril D'Souza, M.D., Yale University School of Medicine 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:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features processed this record on February 27, 2015