NCT00222235

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2 schizophrenia

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

4.4 years

First QC Date

September 13, 2005

Last Update Submit

August 15, 2019

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

schizophreniaschizoaffective disordernegative symptomscognitive impairments

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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.

Interventions

d-cycloserineDRUG
glycineDRUG
placeboDRUG

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCLA/VA Greater Los Angeles Health Care System

Los Angeles, California, 90073, United States

Location

Maryland Psychiatric Research Center

Baltimore, Maryland, 21228, United States

Location

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Nathan S Kline Institute for Psychiatric Research

Orangeburg, New York, 10982, United States

Location

Ezrath Nashim Association, Sarah Herzog Memorial Hospital

Jerusalem, 91531, Israel

Location

Related Publications (1)

  • 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.

    PMID: 17898352DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersCognitive Dysfunction

Interventions

CycloserineGlycine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • William T Carpenter, MD

    Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
P.I.

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

January 1, 2000

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

IL(1)US(4)