Adjunctive Treatment for Decreasing Symptoms of Schizophrenia

August 15, 2019 updated by: MPRC, University of Maryland, Baltimore

Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91531
        • Ezrath Nashim Association, Sarah Herzog Memorial Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90073
        • UCLA/VA Greater Los Angeles Health Care System
    • Maryland
      • Baltimore, Maryland, United States, 21228
        • Maryland Psychiatric Research Center
    • New York
      • Glen Oaks, New York, United States, 11004
        • Zucker Hillside Hospital
      • Orangeburg, New York, United States, 10982
        • Nathan S Kline Institute for Psychiatric Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

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

Investigators

  • Study Chair: William T Carpenter, MD, Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH059807 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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