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Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00128401
First Posted: August 9, 2005
Last Update Posted: May 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Results First Submitted: July 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Phobic Disorders
Anxiety
Social Phobia
Interventions: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
9 participants were enrolled, but not assigned to treatment.

Reporting Groups
  Description
D-cycloserine Subjects were randomized to receive cognitive behavioral therapy with augmentation of D-cycloserine 50 mg administered on day of therapy session. All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent.
Placebo

Subjects were randomized to receive cognitive behavioral therapy with augmentation of placebo administered on day of therapy session.

All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent.


Participant Flow:   Overall Study
    D-cycloserine   Placebo
STARTED   20   19 
COMPLETED   14   15 
NOT COMPLETED   6   4 



  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.
The baseline mean and SD for CGI outcome measure was captured for 42 subjects only. The baseline mean and SD for LSAS outcome measure was captured for 40 subjects. Only 39 subjects were randomized.

Reporting Groups
  Description
D-cycloserine No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   D-cycloserine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   19   39 
Age 
[Units: Participants]
     
<=18 years   7   7   14 
Between 18 and 65 years   13   12   25 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   8   11   19 
Male   12   8   20 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   2   2 
Not Hispanic or Latino   20   17   37 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   6   4   10 
White   12   12   24 
More than one race   0   1   1 
Unknown or Not Reported   1   1   2 
Clinical Global Impressions (CGI) - baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.35  (0.587)   4.278  (0.576)   4.286  (0.554) 
[1] Symptom severity and improvement was assessed using the Clinical Global Impressions scale (CGI). It is a 2-item clinician-administered instrument that measures severity and improvement. One item characterizes subjects at baseline and at each post-baseline visit, based on severity. This is the CGI-S scale. This scale ranges from a score of 1 (normal, not all ill) to 7 (among the most extremely ill patients). The second item, the primary efficacy measure, is only rated after baseline, to quantify the amount of change. This ranges from 1 (completely recovered) to 8 (much worse).
Liebowitz Social Anxiety Scale (LSAS) - baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 89.9  (27.028)   75.588  (25.063)   83.725  (25.910) 
[1] Social anxiety symptoms were assessed using the Liebowitz Social Anxiety Scale (LSAS). It is a 24-item self-report instrument that measures overall social anxiety fear and avoidance symptoms. This is the baseline assessment. The 24 items are each rated twice, from a "0" to "3" scale, with "0" indicated no level of symptom and "3" indicating a high level of the system. One rating is for anxiety, and the other is for avoidance. Thus, the lowest possible score is 0, and the highest possible score is 144. The total score represents the simple sum of all 48 ratings.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Global Improvement (CGI-S) Scale   [ Time Frame: 12 weeks post baseline ]

2.  Secondary:   Liebowitz Social Anxiety Scale (LSAS)   [ Time Frame: 12 weeks post baseline ]


  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 baseline mean and SD for CGI outcome measure was captured for 42 subjects only. The baseline mean and SD for LSAS outcome measure was captured for 40 subjects.


  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: Cameron, Jennifer Ann
Organization: National Institute of Mental Health
phone: +1 301 402 9356
e-mail: cameronj@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00128401     History of Changes
Other Study ID Numbers: 050198
05-M-0198
First Submitted: August 8, 2005
First Posted: August 9, 2005
Results First Submitted: July 1, 2013
Results First Posted: May 20, 2014
Last Update Posted: May 20, 2014