Trial Outcomes & Findings for Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia (NCT NCT00128401)
NCT ID: NCT00128401
Last Updated: 2014-05-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
12 weeks post baseline
Results posted on
2014-05-20
Participant Flow
9 participants were enrolled, but not assigned to treatment.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia
Baseline characteristics by cohort
| Measure |
D-cycloserine
n=20 Participants
|
Placebo
n=19 Participants
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Clinical Global Impressions (CGI) - baseline
|
4.35 Units on a scale
STANDARD_DEVIATION 0.587 • n=5 Participants
|
4.278 Units on a scale
STANDARD_DEVIATION 0.576 • n=7 Participants
|
4.286 Units on a scale
STANDARD_DEVIATION 0.554 • n=5 Participants
|
|
Liebowitz Social Anxiety Scale (LSAS) - baseline
|
89.9 Units on a scale
STANDARD_DEVIATION 27.028 • n=5 Participants
|
75.588 Units on a scale
STANDARD_DEVIATION 25.063 • n=7 Participants
|
83.725 Units on a scale
STANDARD_DEVIATION 25.910 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post baselinePopulation: The analyses included only those subjects who were assigned to the DCS condition and placebo
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.
Outcome measures
| Measure |
D-cycloserine
n=12 Participants
|
Placebo
n=12 Participants
|
|---|---|---|
|
Clinical Global Improvement (CGI-S) Scale
|
4.167 units on a scale
Standard Deviation 0.577
|
3.833 units on a scale
Standard Deviation 0.835
|
SECONDARY outcome
Timeframe: 12 weeks post baselinePopulation: The analyses included only those subjects who were assigned to the DCS condition and placebo
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
| Measure |
D-cycloserine
n=12 Participants
|
Placebo
n=13 Participants
|
|---|---|---|
|
Liebowitz Social Anxiety Scale (LSAS)
|
74.417 units on a scale
Standard Deviation 28.804
|
56.154 units on a scale
Standard Deviation 20.066
|
Adverse Events
D-cycloserine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Not Assigned
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-cycloserine
n=20 participants at risk
|
Placebo
n=19 participants at risk
|
Not Assigned
n=9 participants at risk
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, specify
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Endocrine disorders
Endocrine disorders - Other, specify (Thyroid problem)
|
0.00%
0/20
|
0.00%
0/19
|
11.1%
1/9
|
|
Eye disorders
Eye pain
|
0.00%
0/20
|
10.5%
2/19
|
0.00%
0/9
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
General disorders
Fever
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/9
|
|
General disorders
Flu like symptoms
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
General disorders
General disorders and administration site conditions - Other, specify (Cold symptoms)
|
5.0%
1/20
|
21.1%
4/19
|
0.00%
0/9
|
|
General disorders
General disorders and administration site conditions - Other, specify (Cold)
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/9
|
|
General disorders
General disorders and administration site conditions - Other, specify (congestion)
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
General disorders
General disorders and administration site conditions - Other, specify (missed medication)
|
15.0%
3/20
|
5.3%
1/19
|
0.00%
0/9
|
|
General disorders
General disorders and administration site conditions - Other, specify (missed treatment session)
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
General disorders
General disorders and administration site conditions - Other, specify (Runny nose)
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
General disorders
General disorders and administration site conditions - Other, specify (stopped medication)
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (tail bone cyst)
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (broken left arm)
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20
|
0.00%
0/19
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
10.0%
2/20
|
10.5%
2/19
|
0.00%
0/9
|
|
Psychiatric disorders
Depression
|
5.0%
1/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Uterine pain
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20
|
21.1%
4/19
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus (Itching from broken arm)
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/9
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/9
|
Additional Information
Cameron, Jennifer Ann
National Institute of Mental Health
Phone: +1 301 402 9356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place