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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01450306
First received: October 6, 2011
Last updated: March 25, 2016
Last verified: March 2016

October 6, 2011
March 25, 2016
July 2010
December 2011   (final data collection date for primary outcome measure)
Snake Questionnaire (SNAQ) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

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

Change in blood oxygen level dependent (BOLD) signal in several brain regions of interest [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Brain response to symptom provocation (viewing photographs of snakes) will be measured using functional magnetic resonance imaging (fMRI) at pre- and post-treatment.
Complete list of historical versions of study NCT01450306 on ClinicalTrials.gov Archive Site
  • Clinician's Global Impression (CGI)-Severity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

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

  • Clinician's Global Impression (CGI)-Improvement [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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

  • Snake Questionnaire (SNAQ) [Klorman R, Weerts TC, Hastings JE, Melamed BG, Lang PJ. Psychometric description of some specific fear questionnaires. Behavior Therapy. 1974;5:401-409.] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    30-item self-report scale of severity of snake fear and avoidance
  • Clinician's Global Impression (CGI) [Guy W. Assessment manual for psychopharmacology. Washington, DC: U.S. Government Printing Office; 1976.] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Clinician rating of global illness severity (at pre- and post-treatment) and clinical improvement (at post-treatment).
Not Provided
Not Provided
 
Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Specific Phobia
  • 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
  • Experimental: 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
    Interventions:
    • Drug: D-cycloserine
    • Behavioral: Exposure therapy
  • Placebo Comparator: 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
    Interventions:
    • Behavioral: Exposure therapy
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01450306
NAVE003220HU
Yes
Yes
De-identified data will be made available upon request
Hartford Hospital
Hartford Hospital
Not Provided
Principal Investigator: David Tolin, PhD Hartford Hospital
Hartford Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP