Once Weekly D-cycloserine for Schizophrenia

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00964041
First received: August 20, 2009
Last updated: November 19, 2013
Last verified: November 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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 ]

Enrollment: 0
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964041

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Donald C Goff, M.D. Massachusetts General Hospital
  More Information

No publications provided

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, P50 MH060450, DATR A3-NSC
Study First Received: August 20, 2009
Last Updated: November 19, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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 and Disorders with Psychotic Features
Mental Disorders
Antitubercular Agents
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antibiotics, Antitubercular
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014