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

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ClinicalTrials.gov Identifier: NCT00128401
Recruitment Status : Completed
First Posted : August 9, 2005
Results First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

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
Enrollment 48
Recruitment Details  
Pre-assignment Details 9 participants were enrolled, but not assigned to treatment.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 20 19
Completed 14 15
Not Completed 6 4
Arm/Group Title D-cycloserine Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
<=18 years
7
  35.0%
7
  36.8%
14
  35.9%
Between 18 and 65 years
13
  65.0%
12
  63.2%
25
  64.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
8
  40.0%
11
  57.9%
19
  48.7%
Male
12
  60.0%
8
  42.1%
20
  51.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Hispanic or Latino
0
   0.0%
2
  10.5%
2
   5.1%
Not Hispanic or Latino
20
 100.0%
17
  89.5%
37
  94.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.0%
1
   5.3%
2
   5.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  30.0%
4
  21.1%
10
  25.6%
White
12
  60.0%
12
  63.2%
24
  61.5%
More than one race
0
   0.0%
1
   5.3%
1
   2.6%
Unknown or Not Reported
1
   5.0%
1
   5.3%
2
   5.1%
Clinical Global Impressions (CGI) - baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
4.35  (0.587) 4.278  (0.576) 4.286  (0.554)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
89.9  (27.028) 75.588  (25.063) 83.725  (25.910)
[1]
Measure Description: 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.
1.Primary Outcome
Title Clinical Global Improvement (CGI-S) Scale
Hide Description Symptom severity and improvement was assessed using the Clinical Global Impressions scale (CGI). It is a 2-item clinician-administered instrument that measures the patients' illness severity and global improvement. The minimum value for the CGI is 1=Normal, not at all ill and the maximum value is 7=Among the most extremely ill patients.
Time Frame 12 weeks post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who were assigned to the DCS condition and placebo
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.167  (0.577) 3.833  (0.835)
2.Secondary Outcome
Title Liebowitz Social Anxiety Scale (LSAS)
Hide Description 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.
Time Frame 12 weeks post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who were assigned to the DCS condition and placebo
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
74.417  (28.804) 56.154  (20.066)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Placebo Not Assigned
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
D-cycloserine Placebo Not Assigned
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Placebo Not Assigned
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine Placebo Not Assigned
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/20 (50.00%)   12/19 (63.16%)   1/9 (11.11%) 
Congenital, familial and genetic disorders       
Congenital, familial and genetic disorders - Other, specify  0/20 (0.00%)  1/19 (5.26%)  0/9 (0.00%) 
Endocrine disorders       
Endocrine disorders - Other, specify (Thyroid problem)  0/20 (0.00%)  0/19 (0.00%)  1/9 (11.11%) 
Eye disorders       
Eye pain  0/20 (0.00%)  2/19 (10.53%)  0/9 (0.00%) 
Gastrointestinal disorders       
Diarrhea  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
Hemorrhoids  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
General disorders       
Fever  0/20 (0.00%)  1/19 (5.26%)  0/9 (0.00%) 
Flu like symptoms  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
General disorders and administration site conditions - Other, specify (Cold symptoms)  1/20 (5.00%)  4/19 (21.05%)  0/9 (0.00%) 
General disorders and administration site conditions - Other, specify (Cold)  0/20 (0.00%)  1/19 (5.26%)  0/9 (0.00%) 
General disorders and administration site conditions - Other, specify (congestion)  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
General disorders and administration site conditions - Other, specify (missed medication)  3/20 (15.00%)  1/19 (5.26%)  0/9 (0.00%) 
General disorders and administration site conditions - Other, specify (missed treatment session)  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
General disorders and administration site conditions - Other, specify (Runny nose)  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
General disorders and administration site conditions - Other, specify (stopped medication)  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
Immune system disorders       
Allergic reaction  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
Infections and infestations       
Sinusitis  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorder - Other, specify (tail bone cyst)  0/20 (0.00%)  1/19 (5.26%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, specify (broken left arm)  0/20 (0.00%)  1/19 (5.26%)  0/9 (0.00%) 
Myalgia  2/20 (10.00%)  0/19 (0.00%)  0/9 (0.00%) 
Neck pain  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
Nervous system disorders       
Dizziness  1/20 (5.00%)  1/19 (5.26%)  0/9 (0.00%) 
Headache  2/20 (10.00%)  2/19 (10.53%)  0/9 (0.00%) 
Psychiatric disorders       
Depression  1/20 (5.00%)  1/19 (5.26%)  0/9 (0.00%) 
Reproductive system and breast disorders       
Uterine pain  0/20 (0.00%)  1/19 (5.26%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  2/20 (10.00%)  1/19 (5.26%)  0/9 (0.00%) 
Sore throat  1/20 (5.00%)  4/19 (21.05%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus (Itching from broken arm)  0/20 (0.00%)  1/19 (5.26%)  0/9 (0.00%) 
Surgical and medical procedures       
Surgical and medical procedures - Other, specify  1/20 (5.00%)  0/19 (0.00%)  0/9 (0.00%) 
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.
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
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