fMRI Study Examining Effects of D-cycloserine in Specific Phobia

This study has been completed.
Sponsor:
Collaborator:
University of Kansas
Information provided by (Responsible Party):
Cary Savage, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00591825
First received: December 27, 2007
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

The research team hopes to use brain imaging and mental testing to learn more about specific phobias and the treatment of phobia. When given directly prior to therapy sessions, D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify reasons why D-cycloserine has this effect by measuring brain activity.


Condition Intervention Phase
Phobias
Drug: D-cycloserine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: An fMRI Study Investigating the Effects of Acute D-cycloserine Administration on Brain Activations and Cognitive Functioning in Spider Phobia.

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • fMRI brain activations during 1) symptom provocation and 2) verbal learning. [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive functioning as measures by the following: Wechsler Memory Scale III (Logical Memory and Faces subtests), Rey Complex Figure Test (RCFT), Iowa Gambling Test, Wisconsin Card Sorting Task, and a verbal learning task [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: D-cycloserine
D-cycloserine
Placebo Comparator: 2 Drug: Placebo
Placebo

Detailed Description:

Exposure and Response Prevention (ERP) therapy has become the treatment of choice for specific phobias. ERP involves systematic and repeated exposure to a feared or anxiety-provoking stimulus, leading to habituation and extinction of the fear response. Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS) prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in human subjects with height phobia (a specific phobia) has also demonstrated that DCS facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear extinction by enhancing the learning process and increasing consolidation of memories, but the neural mechanisms underlying this process are not understood. The proposed research aims to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation and verbal recognition one week post-medication. This research will also examine the effects of DCS on cognitive functioning using neuropsychological testing both two house and one week post-medication.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right-handed
  • Adults between 18 and 55 years of age
  • Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for spider phobia.
  • Individuals of both genders and all races will be included

Exclusion Criteria:

  • Women who are breastfeeding or pregnant
  • Individuals with medical conditions unsuitable for MR scanning
  • Individuals reporting a history of epilepsy or seizures
  • Individuals reporting an allergy to cycloserine
  • Individuals diagnosed with asthma or who report previous anaphylactic reaction to insect stings/bites, medication, food, or other material and/or event
  • Individuals reporting present or past diagnosis of a developmental disorder, neurological disorder, or head injury *Individuals found to have Axis I psychopathology as defined by the DSM-IV (other than spider phobia)
  • Individuals currently taking any psychotropic medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591825

Locations
United States, Kansas
University of Kansas Medical Center, Hoglund Brain Imaging Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Cary Savage, Ph.D.
University of Kansas
Investigators
Principal Investigator: Cary Savage, PhD University of Kansas
  More Information

No publications provided

Responsible Party: Cary Savage, Ph.D., Director, CHBN and John H. Wineinger Professor of Psychiatry and Behavioral Sciences, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00591825     History of Changes
Other Study ID Numbers: 10362, GCRC 0046, HSCL 15970
Study First Received: December 27, 2007
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013