Trial record 1 of 1 for:    yohimbine and social phobia
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Yohimbine to Enhance Cognitive Behavioral Therapy (CBT) for Social Anxiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier:
NCT00958880
First received: August 12, 2009
Last updated: September 6, 2013
Last verified: September 2013
Results First Received: May 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Social Anxiety Disorder
Interventions: Behavioral: Group Cognitive Behavioral Therapy
Drug: Yohimbine Hydrochloride
Drug: Sugar Pill

  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 screened for eligibility criteria using an online screen. Potentially eligible participants were invited to the laboratory for a psychiatric interview. Eligible participants were enrolled in the Dallas area from 2009 to 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were not enrolled if they did not meet the study inclusion criteria at a psychiatric screening or medical evaluation designed to rule out contraindicated psychiatric or medical conditions.

Reporting Groups
  Description
Sugar Pill Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
Yohimbine Hydrochloride Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.

Participant Flow:   Overall Study
    Sugar Pill     Yohimbine Hydrochloride  
STARTED     20     20  
COMPLETED     18     18  
NOT COMPLETED     2     2  
Lost to Follow-up                 2                 2  



  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.
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Reporting Groups
  Description
Sugar Pill Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
Yohimbine Hydrochloride Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
Total Total of all reporting groups

Baseline Measures
    Sugar Pill     Yohimbine Hydrochloride     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.70  ± 12.08     35.50  ± 14.02     36.13  ± 12.83  
Gender  
[units: participants]
     
Female     9     5     14  
Male     11     15     26  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   The Liebowitz Social Anxiety Scale (LSAS)   [ Time Frame: LSAS means at 1 month follow-up ]

2.  Secondary:   Social Phobic Disorders Severity and Change Form   [ Time Frame: CGI change scores from baseline to 1 month follow-up ]


  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
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  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: Jasper Smits, Ph.D.
Organization: Southern Methodist University
phone: 214-768-4310
e-mail: jsmits@smu.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier: NCT00958880     History of Changes
Other Study ID Numbers: KS09-088, KS09-088
Study First Received: August 12, 2009
Results First Received: May 30, 2013
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board