Trial Outcomes & Findings for Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics (NCT NCT01450306)

NCT ID: NCT01450306

Last Updated: 2024-03-15

Results Overview

30-item self-report scale of severity of snake fear and avoidance Range: 0-30; higher values indicate greater fear severity

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2024-03-15

Participant Flow

Participant milestones

Measure	D-cycloserine Plus Exposure Therapy 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	Placebo Plus Exposure Therapy Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	D-cycloserine Plus Exposure Therapy n=10 Participants 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	Placebo Plus Exposure Therapy n=10 Participants Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39 years STANDARD_DEVIATION 13.91 • n=5 Participants	34.6 years STANDARD_DEVIATION 12.69 • n=7 Participants	37 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

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

Outcome measures

Measure	D-cycloserine Plus Exposure Therapy n=10 Participants 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	Placebo Plus Exposure Therapy n=10 Participants Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Snake Questionnaire (SNAQ)	9.6 units on a scale Standard Deviation 5.99	9.7 units on a scale Standard Deviation 6.18

SECONDARY outcome

Timeframe: 2 weeks

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

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

Outcome measures

Measure	D-cycloserine Plus Exposure Therapy n=10 Participants 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	Placebo Plus Exposure Therapy n=10 Participants Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Clinician's Global Impression (CGI)-Severity	3 units on a scale Standard Deviation 1.15	2.7 units on a scale Standard Deviation .68

SECONDARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	D-cycloserine Plus Exposure Therapy n=10 Participants 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	Placebo Plus Exposure Therapy n=10 Participants Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Clinician's Global Impression (CGI)-Improvement	8 participants	9 participants

Adverse Events

D-cycloserine Plus Exposure Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Plus Exposure Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	D-cycloserine Plus Exposure Therapy n=10 participants at risk 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	Placebo Plus Exposure Therapy n=10 participants at risk Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1	0.00% 0/10

Additional Information

Dr David Tolin

Hartford Hospital

Phone: 860-545-7685

Email: david.tolin@hhchealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place