Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 49 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

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

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.
ClinicalTrials.gov Identifier: NCT01102803
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : February 21, 2013
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Jasper Smits, Ph.D., Southern Methodist University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Phobic Disorders
Interventions Behavioral: Individual Cognitive Behavioral Therapy (CBT)
Drug: D-Cycloserine
Drug: Placebo
Enrollment 40
Recruitment Details 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 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.
Arm/Group Title Sugar Pill D-Cycloserine
Hide Arm/Group Description Participants will receive sugar pill placebo augmented cognitive behavioral therapy Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
Period Title: Baseline to Post-Treatment
Started 14 15
Completed 11 15
Not Completed 3 0
Reason Not Completed
Lost to Follow-up             3             0
Period Title: Post to Follow-Up
Started 11 15
Completed 10 12
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             3
Arm/Group Title Sugar Pill D-Cycloserine Total
Hide Arm/Group Description Participants will receive sugar pill placebo augmented cognitive behavioral therapy Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
15
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
37.71  (16.81) 29.33  (14.67) 33.8  (15.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
10
  71.4%
10
  66.7%
20
  69.0%
Male
4
  28.6%
5
  33.3%
9
  31.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
1.Primary Outcome
Title Acrophobia Questionnaire With Avoidance (AAVQ)
Hide Description Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0–3) and anxiety (0–6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82–.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DCS+CBT Treatment Placebo+CBT Treatment
Hide Arm/Group Description:
Participants receiving DCS augmented CBT
Participants receiving PL augmented CBT
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.00  (7.41) 12.38  (9.72)
2.Secondary Outcome
Title Attitudes Towards Heights Questionnaire (ATHQ)
Hide Description Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0–10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill D-Cycloserine
Hide Arm/Group Description:
Participants will receive sugar pill placebo augmented cognitive behavioral therapy
Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.67  (8.53) 47.71  (12.98)
3.Secondary Outcome
Title Clinical Global Improvement Scale (CGI)
Hide Description Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either “very much improved” or “much improved” on CGI-I (score ≤ 2). Remission was defined as either “normal” or “minimally ill” on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill D-Cycloserine
Hide Arm/Group Description:
Participants will receive sugar pill placebo augmented cognitive behavioral therapy
Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.27  (.96) 2.00  (.89)
4.Secondary Outcome
Title Behavioral Avoidance Test (BAT)
Hide Description During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0–100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill D-Cycloserine
Hide Arm/Group Description:
Participants will receive sugar pill placebo augmented cognitive behavioral therapy
Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.73  (25.67) 35.55  (25.18)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DCS+CBT Pill Placebo + CBT
Hide Arm/Group Description CBT augmented with DCS (50mg) CBT augmented with sugar pill placebo
All-Cause Mortality
DCS+CBT Pill Placebo + CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DCS+CBT Pill Placebo + CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DCS+CBT Pill Placebo + CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/29 (0.00%) 
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
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
Responsible Party: Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier: NCT01102803     History of Changes
Other Study ID Numbers: KS09-81
First Submitted: April 9, 2010
First Posted: April 13, 2010
Results First Submitted: December 12, 2012
Results First Posted: February 21, 2013
Last Update Posted: February 21, 2013