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

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ClinicalTrials.gov Identifier: NCT00515879
Recruitment Status : Completed
First Posted : August 14, 2007
Results First Posted : July 23, 2015
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stefan G. Hofmann, Boston University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Social Anxiety Disorder
Interventions: Drug: D-cycloserine
Behavioral: Cognitive behavioral therapy (CBT)
Drug: Placebo

  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

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 
Overall Participants Analyzed 
[Units: Participants]
 87   82   169 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      87 100.0%      82 100.0%      169 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.6  (7.89)   30.5  (8.9)   32.55  (8.41) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      44  50.6%      30  36.6%      74  43.8% 
Male      43  49.4%      52  63.4%      95  56.2% 
Region of Enrollment 
[Units: Participants]
     
United States   87   82   169 


  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.  

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.  

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.  

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.  


  Serious Adverse Events


  Other Adverse Events


  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

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: R01MH078308 ( U.S. NIH Grant/Contract )
R01MH075889 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2007
First Posted: August 14, 2007
Results First Submitted: August 2, 2013
Results First Posted: July 23, 2015
Last Update Posted: February 14, 2018