Adjunctive Treatment for Decreasing Symptoms of Schizophrenia
|ClinicalTrials.gov Identifier: NCT00222235|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: d-cycloserine Drug: glycine Drug: placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)|
|Study Start Date :||January 2000|
|Estimated Study Completion Date :||June 2004|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222235
|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|
|Study Chair:||William T Carpenter, MD||Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien|