Adjunctive Treatment for Decreasing Symptoms of Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222235
• Other study ID #: R01MH059807
• Secondary ID: R01MH059807
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2000
• Est. completion date: June 2004

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• d-cycloserine

• glycine

• placebo

Locations

Country	Name	City	State
Israel	Ezrath Nashim Association, Sarah Herzog Memorial Hospital	Jerusalem
United States	Maryland Psychiatric Research Center	Baltimore	Maryland
United States	Zucker Hillside Hospital	Glen Oaks	New York
United States	UCLA/VA Greater Los Angeles Health Care System	Los Angeles	California
United States	Nathan S Kline Institute for Psychiatric Research	Orangeburg	New York

Sponsors (7)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Nathan Kline Institute for Psychiatric Research, National Institute of Mental Health (NIMH), Sarah Herzog Hospital, The Zucker Hillside Hospital, University of California, Los Angeles, University of Maryland, College Park

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 weeks.
Primary	change from baseline on neurocognitive battery measured at 16 weeks.
Secondary	change in psychotic and depressive symptoms measured at 4,8,12, and 16 weeks.
Secondary	changes in extrapyramidal side effects at 4,8,12 and 16 weeks.