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

NCT ID: NCT00237809

Last Updated: 2017-05-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Drug and control CRT

D-serine/control

Group Type EXPERIMENTAL

D-serine

Intervention Type DRUG

D-serine (30 mg/kg)

Cognitive Retraining Placebo

Intervention Type BEHAVIORAL

Cognitive retraining therapy (CRT) control

Drug and CRT

D-serine/cog rehab

Group Type EXPERIMENTAL

D-serine

Intervention Type DRUG

D-serine (30 mg/kg)

Cognitive Retraining (CRT)

Intervention Type BEHAVIORAL

Cognitive retraining therapy (CRT)

Placebo Drug and Placebo CRT

Placebo/control

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo D-serine Drug

Cognitive Retraining Placebo

Intervention Type BEHAVIORAL

Cognitive retraining therapy (CRT) control

Placebo Drug and CRT

Placebo/cog rehab

Group Type EXPERIMENTAL

Cognitive Retraining (CRT)

Intervention Type BEHAVIORAL

Cognitive retraining therapy (CRT)

Placebo

Intervention Type DRUG

Placebo D-serine Drug

Interventions

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D-serine

D-serine (30 mg/kg)

Intervention Type DRUG

Cognitive Retraining (CRT)

Cognitive retraining therapy (CRT)

Intervention Type BEHAVIORAL

Placebo

Placebo D-serine Drug

Intervention Type DRUG

Cognitive Retraining Placebo

Cognitive retraining therapy (CRT) control

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

* Pregnant or lactating
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deepak C D'Souza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10553752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9836012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15780844 (View on PubMed)

Other Identifiers

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DF01-015

Identifier Type: -

Identifier Source: secondary_id

23594

Identifier Type: -

Identifier Source: org_study_id

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