Adjunctive Treatment for Decreasing Symptoms of Schizophrenia
NCT ID: NCT00222235
Last Updated: 2019-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
240 participants
INTERVENTIONAL
2000-01-31
2004-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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d-cycloserine
glycine
placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
54 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
The Zucker Hillside Hospital
OTHER
Nathan Kline Institute for Psychiatric Research
OTHER
University of California, Los Angeles
OTHER
Sarah Herzog Hospital
UNKNOWN
University of Maryland, College Park
OTHER
University of Maryland, Baltimore
OTHER
Responsible Party
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MPRC
P.I.
Principal Investigators
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William T Carpenter, MD
Role: STUDY_CHAIR
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien
Locations
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UCLA/VA Greater Los Angeles Health Care System
Los Angeles, California, United States
Maryland Psychiatric Research Center
Baltimore, Maryland, United States
Zucker Hillside Hospital
Glen Oaks, New York, United States
Nathan S Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Ezrath Nashim Association, Sarah Herzog Memorial Hospital
Jerusalem, , Israel
Countries
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References
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Buchanan RW, Javitt DC, Marder SR, Schooler NR, Gold JM, McMahon RP, Heresco-Levy U, Carpenter WT. The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST): the efficacy of glutamatergic agents for negative symptoms and cognitive impairments. Am J Psychiatry. 2007 Oct;164(10):1593-602. doi: 10.1176/appi.ajp.2007.06081358.
Other Identifiers
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