Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stefan G. Hofmann, Boston University
ClinicalTrials.gov Identifier:
NCT00515879
First received: August 10, 2007
Last updated: July 20, 2015
Last verified: July 2015
Results First Received: August 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Social Anxiety Disorder
Interventions: Drug: D-cycloserine
Behavioral: Cognitive behavioral therapy (CBT)
Drug: Placebo

  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
Prospective participants were recruited between September 2007 and June 2011 through referrals to the three study sites (Boston University [BU], Massachusetts General Hospital [MGH], and Southern Methodist University [SMU]), from other area clinical facilities and programs, and from advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study participants underwent a two-step screening evaluation, consisting of 1) telephone screening, and 2) psychiatric assessment and medical history taking with physical examination.

Reporting Groups
  Description
D-cycloserine-augmented CBT Participants will receive D-cycloserine augmented cognitive behavioral therapy
Placebo-augmented CBT Participants will receive placebo augmented cognitive behavioral therapy

Participant Flow:   Overall Study
    D-cycloserine-augmented CBT     Placebo-augmented CBT  
STARTED     87     82  
COMPLETED     62     62  
NOT COMPLETED     25     20  



  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-augmented CBT Participants will receive D-cycloserine augmented cognitive behavioral therapy
Placebo-augmented CBT Participants will receive placebo augmented cognitive behavioral therapy
Total Total of all reporting groups

Baseline Measures
    D-cycloserine-augmented CBT     Placebo-augmented CBT     Total  
Number of Participants  
[units: participants]
  87     82     169  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     87     82     169  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  34.6  (7.89)     30.5  (8.9)     32.55  (8.41)  
Gender  
[units: participants]
     
Female     44     30     74  
Male     43     52     95  
Region of Enrollment  
[units: participants]
     
United States     87     82     169  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Social Phobic Disorders Severity and Change Form   [ Time Frame: Measured at Months 3 (immediately after treatment) ]

2.  Primary:   Liebowitz Social Anxiety Scale (LSAS)   [ Time Frame: Measured at Months 3 ]

3.  Secondary:   Social Phobia and Anxiety Inventory   [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Quality of Life Enjoyment and Satisfaction Questionnaire   [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Liebowitz Self-Rated Disability Scale   [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Range of Impaired Functioning Tool   [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
None


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Stefan G. Hofmann, Ph.D., Professor of Psychology
Organization: Boston University
phone: 617 353 9233
e-mail: shofmann@bu.edu


Publications:

Responsible Party: Stefan G. Hofmann, Boston University
ClinicalTrials.gov Identifier: NCT00515879     History of Changes
Other Study ID Numbers: R01 MH078308, R01MH078308, R01MH075889
Study First Received: August 10, 2007
Results First Received: August 2, 2013
Last Updated: July 20, 2015
Health Authority: United States: Federal Government