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Once Weekly D-cycloserine for Schizophrenia
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2009
First Received: August 20, 2009   No Changes Posted
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00964041
  Purpose

This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 4, & 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in adult outpatients with schizophrenia.


Condition Intervention Phase
Schizophrenia
 Drug: D-cycloserine
Drug: Placebo
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Mental Health Psychotic Disorders Schizophrenia
Drug Information available for: Cycloserine
U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery. [ Time Frame: Baseline (Week 0) and End of Study (Week 8) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo. [ Time Frame: Baseline (Week 0) and End of Study (Week 8) ] [ Designated as safety issue: No ]
  • Effect of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo. [ Time Frame: Same Day (Single Dose - Week 1) ] [ Designated as safety issue: No ]
  • Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8. [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Assess tolerability and side effects of weekly D-cycloserine compared to placebo [ Time Frame: Weekly measurements for 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
D-cycloserine: Experimental
Participants will receive D-cycloserine weekly, one hour before any assessments, for eight weeks.
Drug: D-cycloserine
50 mg by mouth weekly, one hour before assessments, for eight weeks.
Placebo: Placebo Comparator
Participants will receive placebo weekly, one hour before any assessments, for eight weeks.
Drug: Placebo
Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.

Detailed Description:

In a previous placebo-controlled trial, we demonstrated significant improvement of negative symptoms with once-weekly D-cycloserine treatment. In addition, we found significant improvement of memory consolidation following the first dose; however, the effect on memory consolidation was lost after several weeks. The "practice effect" of weekly measurement of memory consolidation using repeated administration of the Logical Memory Test may have resulted in a "ceiling effect" which would obscure drug/placebo differences. In the current study, we propose to administer the Logical Memory Test at four-week intervals (weeks 1, 4 and 8) to avoid the ceiling effect. We will also add a measurement of negative symptoms at week 4 to better characterize the time course of negative symptom improvement.

Hypotheses:

  1. Assess the effects of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
  2. Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.
  3. Assess the effects of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery at week 8 compared to placebo.
  4. Assess effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.
  5. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female
  2. Age 18-65 years
  3. Diagnosis of schizophrenia or schizoaffective disorder, depressed type
  4. Stable dose of antipsychotic for at least 4 weeks.
  5. Able to provide informed consent
  6. Able to complete a cognitive battery

Exclusion Criteria:

  1. Current treatment with clozapine
  2. Dementia
  3. Seizure disorder
  4. Unstable medical illness
  5. Active substance abuse
  6. Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
  7. Severe renal insufficiency (Serum creatinine > 1.5 mg/dL)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964041

Contacts
Contact: Jared P Walsh, B.A. 617-912-7828 jpwalsh@bu.edu
Contact: Lisa H Raeke, M.A. 617-912-7840 lraeke@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lisa H Raeke, M.A.     617-912-7840     lraeke@partners.org    
Contact: Jared P Walsh, B.A.     617-912-7828     jpwalsh@bu.edu    
Principal Investigator: Donald C Goff, M.D.            
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Donald C Goff, M.D. Massachusetts General Hospital
  More Information

Publications:
Goff DC, Cather C, Gottlieb JD, Evins AE, Walsh J, Raeke L, Otto MW, Schoenfeld D, Green MF. Once-weekly D-cycloserine effects on negative symptoms and cognition in schizophrenia: an exploratory study. Schizophr Res. 2008 Dec;106(2-3):320-7. Epub 2008 Sep 16.

Responsible Party: Massachusetts General Hospital ( Donald C. Goff, M.D. )
Study ID Numbers: 2009-P-001341, P50 MH060450, DATR A3-NSC
Study First Received: August 20, 2009
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00964041     History of Changes
Health Authority: United States: Federal Government;   United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by National Institute of Mental Health (NIMH):
Cognitive Impairment
Neuroplasticity
D-cycloserine
NMDA
Anti-Bacterial Agents
 Mental Disorders
Psychotic Disorders
Antitubercular Agents
Schizophrenia and Disorders with Psychotic Features
Schizoaffective Disorder

Additional relevant MeSH terms:
Cycloserine
Antimetabolites
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Pharmacologic Actions
 Antibiotics, Antitubercular
Schizophrenia
Anti-Bacterial Agents
Mental Disorders
Therapeutic Uses
Antitubercular Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2009



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