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Adjunctive Treatment for Decreasing Symptoms of Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
The Zucker Hillside Hospital
Nathan Kline Institute for Psychiatric Research
University of California, Los Angeles
Sarah Herzog Hospital
University of Maryland
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00222235
First received: September 13, 2005
Last updated: February 23, 2006
Last verified: August 2004
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: d-cycloserine
Drug: glycine
Drug: placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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

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

Estimated Enrollment: 240
Study Start Date: January 2000
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222235

Locations
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
Israel
Ezrath Nashim Association, Sarah Herzog Memorial Hospital
Jerusalem, Israel, 91531
Sponsors and Collaborators
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
Investigators
Study Chair: William T Carpenter, MD Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00222235     History of Changes
Other Study ID Numbers: H59807
Study First Received: September 13, 2005
Last Updated: February 23, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):
schizophrenia
schizoaffective disorder
negative symptoms
cognitive impairments

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Cycloserine
Glycine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Glycine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013