D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia
June 15, 2012 updated by: Deepak C. D'Souza, Yale University
D-Serine Augmentation of Cognitive Retraining in Schizophrenia
This study will examine the effectiveness of D-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karnataka
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Bangalore, Karnataka, India, 560029
- National Institute of Mental Health and Neurosciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Positive and Negative Syndrome Scale (PANSS)
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Wisconsin Card Sorting Test (WCST)
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Hopkins Verbal Learning Test
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Spatial working memory task
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Secondary Outcome Measures
Outcome Measure |
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Heinrichs-Carpenter Quality of Life Scale
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Neurocognitive training tasks
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Functional assessments
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Deepak C. D'Souza, MD, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tsai GE, Yang P, Chung LC, Tsai IC, Tsai CW, Coyle JT. D-serine added to clozapine for the treatment of schizophrenia. Am J Psychiatry. 1999 Nov;156(11):1822-5. doi: 10.1176/ajp.156.11.1822.
- Tsai G, Yang P, Chung LC, Lange N, Coyle JT. D-serine added to antipsychotics for the treatment of schizophrenia. Biol Psychiatry. 1998 Dec 1;44(11):1081-9. doi: 10.1016/s0006-3223(98)00279-0.
- Heresco-Levy U, Javitt DC, Ebstein R, Vass A, Lichtenberg P, Bar G, Catinari S, Ermilov M. D-serine efficacy as add-on pharmacotherapy to risperidone and olanzapine for treatment-refractory schizophrenia. Biol Psychiatry. 2005 Mar 15;57(6):577-85. doi: 10.1016/j.biopsych.2004.12.037.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
June 18, 2012
Last Update Submitted That Met QC Criteria
June 15, 2012
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RPA/020/03
- 1R01DA022495 (U.S. NIH Grant/Contract)
- 103T-363
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.