Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00963924
First received: August 20, 2009
Last updated: July 31, 2014
Last verified: July 2014
Results First Received: June 23, 2014  
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
Condition: Schizophrenia
Interventions: Drug: D-cycloserine
Drug: Placebo
Behavioral: Cognitive Remediation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
54 patients were assessed for eligibility; however, 14 were excluded (11 were ineligible, and 3 withdrew consent). 40 participants were randomized, however 4 were excluded (1 serious adverse event, 2 withdrew consent, and 1 was lost to follow up), therefore 36 entered the treatment phase.

Reporting Groups
  Description
D-cycloserine Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.

Participant Flow:   Overall Study
    D-cycloserine     Placebo  
STARTED     18     18  
COMPLETED     17     15  
NOT COMPLETED     1     3  
Adverse Event                 1                 0  
Withdrawal by Subject                 0                 1  
Changed antipsychotic                 0                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
  Description
D-cycloserine Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Total Total of all reporting groups

Baseline Measures
    D-cycloserine     Placebo     Total  
Number of Participants  
[units: participants]
  18     18     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     18     36  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.8  ± 11.5     46.2  ± 13.3     47.5  ± 12.4  
Gender  
[units: participants]
     
Female     2     3     5  
Male     16     15     31  
Region of Enrollment  
[units: participants]
     
United States     18     18     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)   [ Time Frame: Baseline vs. Week 8 ]

2.  Secondary:   Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: Baseline ]

3.  Secondary:   Scale for Assessment of Negative Symptoms (SANS)   [ Time Frame: Baseline vs. Week 8 ]

4.  Secondary:   Global Assessment of Functioning Scale (GAS)   [ Time Frame: Baseline ]

5.  Secondary:   Heinrich Quality of Life Scale (QoL)   [ Time Frame: Baseline ]

6.  Secondary:   Calgary Depression Scale for Schizophrenia (CDSS)   [ Time Frame: Baseline ]

7.  Secondary:   Clinical Global Impression (CGI)   [ Time Frame: Weeks 0 and 8, and Month 6 after cognitive remediation completion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Side Effects Checklist (SEC)   [ Time Frame: Weeks 0 - 8, and Month 6 after cognitive remediation completion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Dr. Donald C Goff
Organization: Nathan Klein Institute for Psychiatric Research
phone: 646-754-4843
e-mail: donald.goff@nyumc.org


Publications of Results:

Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00963924     History of Changes
Other Study ID Numbers: 2008P002237, 5P50MH060450, 5P50 MH060450, DATR A3-NSC
Study First Received: August 20, 2009
Results First Received: June 23, 2014
Last Updated: July 31, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board