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Exposure, D-cycloserine Enhancement, and fMRI in Snake Phobics

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01450306
First received: October 6, 2011
Last updated: October 11, 2011
Last verified: October 2011
History of Changes

October 6, 2011
October 11, 2011
July 2010
July 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01450306 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Exposure, D-cycloserine Enhancement, and fMRI in Snake Phobics
Exposure, D-cycloserine Enhancement, and 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.
Not Provided
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
  • Experimental: D-cycloserine plus exposure therapy
    Interventions:
    • Drug: D-cycloserine
    • Behavioral: Exposure therapy
  • Placebo Comparator: Placebo plus exposure therapy
    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.
 
Active, not recruiting
20
November 2011
July 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
Hartford Hospital
Hartford Hospital
Not Provided
Principal Investigator: David Tolin, PhD Hartford Hospital
Hartford Hospital
October 2011

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