Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics

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: NCT01450306
Recruitment Status : Completed
First Posted : October 12, 2011
Results First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Specific Phobia
Interventions Drug: D-cycloserine
Behavioral: Exposure therapy
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Hide Arm/Group Description Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy Total
Hide Arm/Group Description Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
39  (13.91) 34.6  (12.69) 37  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
6
  60.0%
12
  60.0%
Male
4
  40.0%
4
  40.0%
8
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Snake Questionnaire (SNAQ)
Hide Description

30-item self-report scale of severity of snake fear and avoidance

Range: 0-30; higher values indicate greater fear severity

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Hide Arm/Group Description:
Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.6  (5.99) 9.7  (6.18)
2.Secondary Outcome
Title Clinician's Global Impression (CGI)-Severity
Hide Description

Clinician rating of global illness severity (at pre- and post-treatment)

CGI-Severity range 1-7; higher scores indicate greater illness severity.

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Hide Arm/Group Description:
Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
3  (1.15) 2.7  (.68)
3.Secondary Outcome
Title Clinician's Global Impression (CGI)-Improvement
Hide Description

Clinician rating of global illness severity (at post-treatment)

CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Hide Arm/Group Description:
Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
8 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Hide Arm/Group Description Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
All-Cause Mortality
D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
D-cycloserine Plus Exposure Therapy Placebo Plus Exposure Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/10 (0.00%)    
Gastrointestinal disorders     
Nausea  [1]  1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Mild nausea, resolved without intervention
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr David Tolin
Organization: Hartford Hospital
Phone: 860-545-7685
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01450306     History of Changes
Other Study ID Numbers: NAVE003220HU
First Submitted: October 6, 2011
First Posted: October 12, 2011
Results First Submitted: May 24, 2012
Results First Posted: April 21, 2016
Last Update Posted: April 21, 2016