fMRI Study Examining Effects of D-cycloserine in Specific Phobia

NCT ID: NCT00591825

Last Updated: 2017-06-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Phobias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-Phobic Control - Placebo

Participants without phobia will be given one placebo administration.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Non-Phobic Control - DCS

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

Group Type ACTIVE_COMPARATOR

D-cycloserine

Intervention Type DRUG

D-cycloserine

Spider-phobic Placebo

Participants with phobia will be given one placebo administration.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Spider-phobic DCS

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

Group Type EXPERIMENTAL

D-cycloserine

Intervention Type DRUG

D-cycloserine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

D-cycloserine

D-cycloserine

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cycloserine Sugar pill

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Psychological Foundation

OTHER

Sponsor Role collaborator

American Psychological Association

UNKNOWN

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cary Savage, Ph.D.

Director, CHBN and John H. Wineinger Professor of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cary Savage, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kansas Medical Center, Hoglund Brain Imaging Center

Kansas City, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GCRC 0046

Identifier Type: OTHER

Identifier Source: secondary_id

HSCL 15970

Identifier Type: OTHER

Identifier Source: secondary_id

10362

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurofeedback in Clinical High Risk
NCT06492343 NOT_YET_RECRUITING NA