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Once Weekly D-cycloserine for Schizophrenia

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ClinicalTrials.gov Identifier: NCT00964041
Recruitment Status : Withdrawn
First Posted : August 24, 2009
Last Update Posted : November 20, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: D-cycloserine Drug: Placebo Phase 4

Detailed Description:

In a previous placebo-controlled trial, investigators demonstrated significant improvement of negative symptoms with once-weekly D-cycloserine treatment. In addition, investigators 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, investigators propose to administer the Logical Memory Test at four-week intervals (weeks 1, 4 and 8) to avoid the ceiling effect. Additionally a measurement will be added 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia.
Study Start Date : July 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Cycloserine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: D-cycloserine
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.
Other Names:
  • Seromycin
  • Cycloserine
Placebo Comparator: Placebo
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.



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8. [ Time Frame: Week 4 and Week 8 ]
  4. Assess tolerability and side effects of weekly D-cycloserine compared to placebo [ Time Frame: Weekly measurements for 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964041


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Donald C Goff, M.D. Massachusetts General Hospital

Responsible Party: Donald C. Goff, MD, Director of the Schizophrenia Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00964041     History of Changes
Other Study ID Numbers: 2009-P-001341
P50MH060450 ( U.S. NIH Grant/Contract )
DATR A3-NSC
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Keywords provided by Donald C. Goff, MD, Massachusetts General Hospital:
Cognitive Impairment
Neuroplasticity
D-cycloserine
N-methyl-D-aspartate (NMDA)
Anti-Bacterial Agents
Mental Disorders
Psychotic Disorders
Antitubercular Agents
Schizophrenia and Disorders with Psychotic Features
Schizoaffective Disorder

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action