fMRI Study Examining Effects of D-cycloserine in Specific Phobia
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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. |
- fMRI brain activations during 1) symptom provocation and 2) verbal learning. [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
- 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 |
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| United States, Kansas | |
| University of Kansas Medical Center, Hoglund Brain Imaging Center | |
| Kansas City, Kansas, United States, 66160 | |
| 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