search
Back to results

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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
D-serine
Cognitive retraining
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Mental Health and Neurosciences

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
June 15, 2012
Sponsor
Yale University
Collaborators
Stanley Medical Research Institute, Donaghue Foundation, US Department of Veterans Affairs, VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00237848
Brief Title
D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia
Official Title
D-Serine Augmentation of Cognitive Retraining in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
Stanley Medical Research Institute, Donaghue Foundation, US Department of Veterans Affairs, VA Office of Research and Development

4. Oversight

5. Study Description

Brief Summary
This study will examine the effectiveness of D-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
D-serine
Intervention Type
Behavioral
Intervention Name(s)
Cognitive retraining
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Title
Wisconsin Card Sorting Test (WCST)
Title
Hopkins Verbal Learning Test
Title
Spatial working memory task
Secondary Outcome Measure Information:
Title
Heinrichs-Carpenter Quality of Life Scale
Title
Neurocognitive training tasks
Title
Functional assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak C. D'Souza, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Mental Health and Neurosciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560029
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
10553752
Citation
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.
Results Reference
background
PubMed Identifier
9836012
Citation
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.
Results Reference
background
PubMed Identifier
15780844
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs