D-Cycloserine to Enhance Cognitive Behavioral Therapy (CBT) for Acrophobia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier:
NCT01102803
First received: April 9, 2010
Last updated: January 18, 2013
Last verified: December 2012
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Phobic Disorders
Interventions: Behavioral: Individual Cognitive Behavioral Therapy (CBT)
Drug: D-Cycloserine
Drug: Placebo

  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 (N = 29; Mean age = 33.38) with acrophobia were recruited from Southern Methodist University and the greater Dallas area from 2009 to 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
76 individuals were assessed for eligibility, of which 47 were excluded due to not having a diagnosis of acrophobia (n=37) or declining participation (n=10). 29 individuals were randomized and no participants were excluded after enrollment but prior to group assignment.

Reporting Groups
  Description
Sugar Pill Participants will receive sugar pill placebo augmented cognitive behavioral therapy
D-Cycloserine Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy

Participant Flow for 2 periods

Period 1:   Baseline to Post-Treatment
    Sugar Pill     D-Cycloserine  
STARTED     14     15  
COMPLETED     11     15  
NOT COMPLETED     3     0  
Lost to Follow-up                 3                 0  

Period 2:   Post to Follow-Up
    Sugar Pill     D-Cycloserine  
STARTED     11     15  
COMPLETED     10     12  
NOT COMPLETED     1     3  
Lost to Follow-up                 1                 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
  Description
Sugar Pill Participants will receive sugar pill placebo augmented cognitive behavioral therapy
D-Cycloserine Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
Total Total of all reporting groups

Baseline Measures
    Sugar Pill     D-Cycloserine     Total  
Number of Participants  
[units: participants]
  14     15     29  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     15     29  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.71  ± 16.81     29.33  ± 14.67     33.8  ± 15.74  
Gender  
[units: participants]
     
Female     10     10     20  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     14     15     29  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Acrophobia Questionnaire With Avoidance (AAVQ)   [ Time Frame: 2 months ]

2.  Secondary:   Attitudes Towards Heights Questionnaire (ATHQ)   [ Time Frame: 2 months ]

3.  Secondary:   Clinical Global Improvement Scale (CGI)   [ Time Frame: 2 months ]

4.  Secondary:   Behavioral Avoidance Test (BAT)   [ Time Frame: 2 months ]


  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
Sample may not have been severe enough to see an effect of DCS; there may have been a ceiling effect; there was no pre-session pill administration; assessors were blind but not independent; only one dose of DCS was examined


  More Information
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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: Dr. Jasper Smits
Organization: Southern Methodist University
phone: 214-768-4125
e-mail: jsmits@smu.edu


No publications provided by Southern Methodist University

Publications automatically indexed to this study:

Responsible Party: Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier: NCT01102803     History of Changes
Other Study ID Numbers: KS09-81
Study First Received: April 9, 2010
Results First Received: December 12, 2012
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board