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Adjunctive Treatment for Decreasing Symptoms of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00222235
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 20, 2019
National Institute of Mental Health (NIMH)
The Zucker Hillside Hospital
Nathan Kline Institute for Psychiatric Research
University of California, Los Angeles
Sarah Herzog Hospital
University of Maryland, College Park
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore

Brief Summary:
This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: d-cycloserine Drug: glycine Drug: placebo Phase 2 Phase 3

Detailed Description:

A double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen.

Multicenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the NMDA receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. After an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. Patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)
Actual Study Start Date : January 2000
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 weeks.
  2. change from baseline on neurocognitive battery measured at 16 weeks.

Secondary Outcome Measures :
  1. change in psychotic and depressive symptoms measured at 4,8,12, and 16 weeks.
  2. changes in extrapyramidal side effects at 4,8,12 and 16 weeks.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosis of schizophrenia or schizoaffective disorder
  • stable, enduring negative symptoms above a certain level (SANS >19)
  • clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15
  • extrapyramidal symptoms measured on SAS below 9
  • on stable antipsychotic regimen (not including clozapine)

Exclusion Criteria:

  • alcohol or substance dependence within last six months
  • alcohol or substance abuse within last month
  • organic brain disorder
  • medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus
  • Female participants could not be pregnant and were required to be using a documented method of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00222235

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United States, California
UCLA/VA Greater Los Angeles Health Care System
Los Angeles, California, United States, 90073
United States, Maryland
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228
United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Nathan S Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10982
Ezrath Nashim Association, Sarah Herzog Memorial Hospital
Jerusalem, Israel, 91531
Sponsors and Collaborators
University of Maryland, Baltimore
National Institute of Mental Health (NIMH)
The Zucker Hillside Hospital
Nathan Kline Institute for Psychiatric Research
University of California, Los Angeles
Sarah Herzog Hospital
University of Maryland, College Park
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Study Chair: William T Carpenter, MD Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MPRC, P.I., University of Maryland, Baltimore Identifier: NCT00222235    
Other Study ID Numbers: R01MH059807 ( U.S. NIH Grant/Contract )
R01MH059807 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by MPRC, University of Maryland, Baltimore:
schizoaffective disorder
negative symptoms
cognitive impairments
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Glycine Agents
Neurotransmitter Agents
Physiological Effects of Drugs