fMRI Study Examining Effects of D-cycloserine in Specific Phobia

NCT00591825 | Completed Phase 2 Results

• 3 other identifiers: 10362GCRC 0046HSCL 15970
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phobias

Outcome Measures

Primary Outcomes (1)

• fMRI Brain Activations During Symptom Provocation

  Regions of interest (ROIs) were specified based on previous research and included amygdala, insula, dorsal anterior cingulate cortex (ACC), dorsolateral PFC (dlPFC), and hippocampus. Multiple regression analyses were used to examine differences in response between experimental conditions (spider versus butterfly images). For significant clusters of activation within ROIs, the average max percent signal change is reported. For other regions, the average max percent signal change is reported within a sphere centered at coordinates identified via previous research.

  2 Weeks

Secondary Outcomes (4)

• Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests)

  2 Weeks

• Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT)

  2 weeks

• Cognitive Functioning Measured Using the Iowa Gambling Test

  2 weeks

• Cognitive Functioning Measured Using the Wisconsin Card Sorting Task

  2 weeks

Study Arms (4)

Non-Phobic Control - Placebo

PLACEBO COMPARATOR

Participants without phobia will be given one placebo administration.

Drug: Placebo

Non-Phobic Control - DCS

ACTIVE COMPARATOR

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

Drug: D-cycloserine

Spider-phobic Placebo

PLACEBO COMPARATOR

Participants with phobia will be given one placebo administration.

Drug: Placebo

Spider-phobic DCS

EXPERIMENTAL

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

Drug: D-cycloserine

Interventions

D-cycloserine DRUG

D-cycloserine

Also known as: Cycloserine

Non-Phobic Control - DCS; Spider-phobic DCS

Placebo DRUG

Placebo

Also known as: Sugar pill

Non-Phobic Control - Placebo; Spider-phobic Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• American Psychological Foundation: collaborator
• American Psychological Association: collaborator

Study Sites (1)

University of Kansas Medical Center, Hoglund Brain Imaging Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Phobic Disorders

Interventions

Cycloserine; Sugars

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Results Point of Contact

• Title: Robin Aupperle, PhD
• Organization: Laureate Institute for Brain Research (LIBR)

raupperle@laureateinstitute.org

(913) 588-9078

Study Officials

• Cary Savage, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, CHBN and John H. Wineinger Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: March 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 5, 2017
• Results First Posted: June 5, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)