Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital Identifier:
First received: April 2, 2007
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: June 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: d-cycloserine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were stable adult outpatients at an urban community mental health center, ages 18-65 years, with a diagnosis of schizophrenia .

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
D-cycloserine 50 mg d-cycloserine
Placebo 50 mg placebo

Participant Flow:   Overall Study
    D-cycloserine     Placebo  
STARTED     19     19  
COMPLETED     16     16  
NOT COMPLETED     3     3  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
D-cycloserine 50 mg d-cycloserine
Placebo 50 mg placebo
Total Total of all reporting groups

Baseline Measures
    D-cycloserine     Placebo     Total  
Number of Participants  
[units: participants]
  19     19     38  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     19     19     38  
>=65 years     0     0     0  
[units: years]
Mean ± Standard Deviation
  50.1  ± 9.15     48  ± 6.66     49.05  ± 7.905  
[units: participants]
Female     9     6     15  
Male     10     13     23  
Region of Enrollment  
[units: participants]
United States     19     19     38  

  Outcome Measures
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1.  Primary:   Main Outcome Measure: The Change From Baseline to Week 8 on the SANS   [ Time Frame: Baseline score vs. Week 8 ]

2.  Secondary:   Treatment Effects on the Positive Syndrome Subscale of the PANSS   [ Time Frame: Baseline score vs. Week 8 score ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As the first study of once-weekly dosing in Schizophrenia, this study was exploratory and so results must be considered preliminary. Additional studies are needed to replicate these findings.

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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Donald C Goff
Organization: Massachusetts General Hopsital
phone: 617-912-7899

Publications of Results:

Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital Identifier: NCT00455702     History of Changes
Other Study ID Numbers: 2005-P-001040
Study First Received: April 2, 2007
Results First Received: June 11, 2014
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board