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

NCT00237848 | Completed Phase 3

• 3 other identifiers: RPA/020/031R01DA022495103T-363
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (4)

• Positive and Negative Syndrome Scale (PANSS)

• Wisconsin Card Sorting Test (WCST)

• Hopkins Verbal Learning Test

• Spatial working memory task

Secondary Outcomes (3)

• Heinrichs-Carpenter Quality of Life Scale

• Neurocognitive training tasks

• Functional assessments

Interventions

D-serine DRUG

Cognitive retraining BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Stanley Medical Research Institute: collaborator
• Donaghue Foundation: collaborator
• US Department of Veterans Affairs: collaborator
• VA Office of Research and Development: collaborator

Study Sites (1)

National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, 560029, India

Location

Related Publications (3)

• 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.

  PMID: 10553752 BACKGROUND

• 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.

  PMID: 9836012 BACKGROUND

• 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.

  PMID: 15780844 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Deepak C. D'Souza, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: October 12, 2005
• Study Start: February 1, 2005
• Last Updated: June 18, 2012

Record last verified: 2008-04

Locations

IN (1)