fMRI Study Examining Effects of D-cycloserine in Specific Phobia

University of Kansas

Status and phase: Completed; Phase 2

Conditions: Phobias

Treatments: Drug: D-cycloserine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00591825

10362

GCRC 0046 (Other Identifier)

HSCL 15970 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 4 patient groups, including a placebo group

Non-Phobic Control - Placebo

Placebo Comparator group

Description:

Participants without phobia will be given one placebo administration.

Treatment:

Drug: Placebo

Non-Phobic Control - DCS

Active Comparator group

Description:

Participants without phobia will be given one D-cycloserine (DCS) administration of 100mg.

Treatment:

Drug: D-cycloserine

Spider-phobic Placebo

Placebo Comparator group

Description:

Participants with phobia will be given one placebo administration.

Treatment:

Drug: Placebo

Spider-phobic DCS

Experimental group

Description:

Participants with phobia will be given one D-cycloserine (DCS) administration of 100mg.

Treatment:

Drug: D-cycloserine