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

Specific Phobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450306
• Other study ID #: NAVE003220HU
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2024
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.

Description:

D-cycloserine (DCS) is a partial N-methyl-D-aspartate (NMDA) receptor agonist that may improve or accelerate extinction learning. We will randomly assign people with snake phobia to receive DCS or placebo, and then provide all participants with exposure therapy. We will examine whether people receiving DCS and vs. placebo show different brain reactions to symptom provocation before and after exposure therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis of specific phobia (snakes)

Exclusion Criteria:

• History of psychosis, obsessive-compulsive disorder, or mania

• Recent substance abuse or suicidality

• Previous receipt of study treatments

Related Conditions & MeSH terms

• Specific Phobia

Intervention

Drug:
• D-cycloserine
50 mg d-cycloserine, oral, 1 dose

Behavioral:
• Exposure therapy
Single session graded in vivo exposure therapy, 60-180 minutes

Drug:
• Placebo
Single capsule of oral placebo, administered once 1 hr prior to exposure therapy

Locations

Country	Name	City	State
United States	Institute of Living/Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nave AM, Tolin DF, Stevens MC. Exposure therapy, D-cycloserine, and functional magnetic resonance imaging in patients with snake phobia: a randomized pilot study. J Clin Psychiatry. 2012 Sep;73(9):1179-86. doi: 10.4088/JCP.11m07564. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Snake Questionnaire (SNAQ)	30-item self-report scale of severity of snake fear and avoidance; Range: 0-30; higher values indicate greater fear severity	2 weeks
Secondary	Clinician's Global Impression (CGI)-Severity	Clinician rating of global illness severity (at pre- and post-treatment); CGI-Severity range 1-7; higher scores indicate greater illness severity.	2 weeks
Secondary	Clinician's Global Impression (CGI)-Improvement	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	2 weeks