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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00237809
• Other study ID #: 23594
• Secondary ID: DF01-015
• Status: Recruiting
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 30, 2010
• Start date: September 2002
• Est. completion date: December 2010

Study information

• Verified date: August 2010
• Source: Yale University
• Contact: Rajiv Radhakrishnan, MD
• Phone: 203-932-5711
• Email: rajiv.radhakrishnan[@]yale.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

• Pregnant or lactating

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• D-serine
D-serine (30 mg/kg)

Behavioral:
• Cognitive retraining
Cog rehab

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Donaghue Medical Research Foundation, National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WCST		12 weeks	No
Primary	Hopkins Verbal Learning Test		12 weeks	No
Primary	Spatial working memory task		12 weeks	No
Primary	PANSS		12 weeks	No
Secondary	Heinrichs-Carpenter Quality of Life Scale		12 weeks	No
Secondary	Neurocognitive training tasks		12 weeks	No
Secondary	Functional assessments		12 weeks	No