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Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00455702
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital

Brief Summary:
The study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and side-effects.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: d-cycloserine Phase 4

Detailed Description:

This is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 2, 3. 4, 5, 6, 7, 8 & 10 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia.

Specific aims:

  1. Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo.
  2. Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo.
  3. Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo.
  4. Assess the persistence of learned information in a no-treatment follow-up assessment at Week 10 in the D-cycloserine group compared to the placebo group.
  5. Assess effects of weekly D-cycloserine dosing on positive & negative symptoms at week 8 compared to placebo.
  6. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
  7. Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo.
  8. Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 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
Study Start Date : July 2004
Primary Completion Date : April 2007
Study Completion Date : April 2007

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
50 mg d-cycloserine
Drug: d-cycloserine
50mg dose d-cycloserine v placebo
Placebo Comparator: Placebo
50 mg placebo
Drug: d-cycloserine
50mg dose d-cycloserine v placebo



Primary Outcome Measures :
  1. Main Outcome Measure: The Change From Baseline to Week 8 on the SANS [ Time Frame: Baseline score vs. Week 8 ]
    The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).


Secondary Outcome Measures :
  1. Treatment Effects on the Positive Syndrome Subscale of the PANSS [ Time Frame: Baseline score vs. Week 8 score ]
    The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).



Information from the National Library of Medicine

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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.

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): NCT00455702


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

Publications:
Responsible Party: Donald C. Goff, MD, Director of the Schizophrenia Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00455702     History of Changes
Other Study ID Numbers: 2005-P-001040
First Posted: April 4, 2007    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014
Last Verified: July 2014

Keywords provided by Donald C. Goff, MD, Massachusetts General Hospital:
schizophrenia
cognition
d-cycloserine
memory

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