Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00742079
First received: August 25, 2008
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: August 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: D-cycloserine
Behavioral: Cognitive Behavioral Therapy

  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 recruited from an urban community mental health center in Boston, MA from September 2006 to May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
31 participants were screened, 10 were excluded (7 did not meet inclusion criteria and 2 refused to participate, 1 excluded for reasons not listed in study publication)

Reporting Groups
  Description
1 D-cycloserine First, Then Placebo Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
2 Placebo First, Then D-cycloserine Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.

Participant Flow:   Overall Study
    1 D-cycloserine First, Then Placebo     2 Placebo First, Then D-cycloserine  
STARTED     11     10  
Baseline/Week 1 (Received Dose 1)     11     9  
Week 2 (Received Dose 2)     11     9  
COMPLETED     11     9  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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
  Description
1 D-cycloserine, Then Placebo Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
2 Placebo, Then D-cycloserine Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
Total Total of all reporting groups

Baseline Measures
    1 D-cycloserine, Then Placebo     2 Placebo, Then D-cycloserine     Total  
Number of Participants  
[units: participants]
  11     10     21  
Age  
[units: years]
Mean ± Standard Deviation
  49.2  ± 9.0     51.4  ± 13.0     50.2  ± 10.7  
Gender  
[units: participants]
     
Female     5     2     7  
Male     6     8     14  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     2     4  
White     7     6     13  
More than one race     0     0     0  
Unknown or Not Reported     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     11     10     21  



  Outcome Measures

1.  Primary:   Alternative Beliefs Assessment   [ Time Frame: Baseline vs. Week 1 vs. Week 2 ]

2.  Secondary:   Predictors of Response to D-cycloserine Facilitation of CBT for Delusions in Baseline Characteristics   [ Time Frame: Measured at baseline ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Psychotic Rating Scales (PSYRATS)   [ Time Frame: Measured at Baseline, Week 1 and Week 2 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Beck Cognitive Insight Scale (BCIS)   [ Time Frame: Measured at Baseline, Week 1, and Week 2 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Bead Task Measuring Probabilistic Reasoning   [ Time Frame: Measured at Baseline, Week 1, and Week 2 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Affective Salience Task   [ Time Frame: Measured at Baseline, Week 1, and Week 2 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Select Items From the Maudsley Assessment of Delusions Scale   [ Time Frame: Measured at Baseline, Week 1, and Week 2 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
The cross-over design of this study produced results that are difficult to interpret due to a significant order effect. Larger and longer trials are needed to assess whether this treatment may benefit patients with medication resistant delusions.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Gottlieb, PhD
Organization: Massachusetts General Hospital
phone: 617-912-7800
e-mail: jgottlieb2@partners.org


Publications of Results:

Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00742079     History of Changes
Other Study ID Numbers: P50 MH060450, 2P50MH060450-07A1, DATR A3-NSC
Study First Received: August 25, 2008
Results First Received: August 11, 2014
Last Updated: September 3, 2014
Health Authority: United States: Federal Government