Clinical trial NCT00222235: Adjunctive Treatment for Decreasing Symptoms of Schizophrenia
Official title: Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
schizoaffective disorder
negative symptoms
cognitive impairments
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: The Zucker Hillside Hospital
name: Nathan Kline Institute for Psychiatric Research
name: University of California, Los Angeles
name: Sarah Herzog Hospital
name: University of Maryland, College Park
First posted: 2005-09-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 weeks.
measure: change from baseline on neurocognitive battery measured at 16 weeks.
Secondary outcomes:
measure: change in psychotic and depressive symptoms measured at 4,8,12, and 16 weeks.
measure: changes in extrapyramidal side effects at 4,8,12 and 16 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA/VA Greater Los Angeles Health Care System
state: California
city: Baltimore
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
city: Orangeburg
country: United States
facility: Nathan S Kline Institute for Psychiatric Research
state: New York
city: Jerusalem
country: Israel
facility: Ezrath Nashim Association, Sarah Herzog Memorial Hospital
Study officials:
affiliation: Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien
name: William T Carpenter, MD
role: STUDY_CHAIR
References:
citation: 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.