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Trial record 36 of 120 for:    CYCLOSERINE OR SEROMYCIN

fMRI Study Examining Effects of D-cycloserine in Specific Phobia

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ClinicalTrials.gov Identifier: NCT00591825
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
American Psychological Foundation
Nepalese Psychological Association
Information provided by (Responsible Party):
Cary Savage, Ph.D., University of Kansas

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.

Condition or disease Intervention/treatment Phase
Phobias Drug: D-cycloserine Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : March 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias
Drug Information available for: Cycloserine

Arm Intervention/treatment
Placebo Comparator: Non-Phobic Control - Placebo
Participants without phobia will be given one placebo administration.
Drug: Placebo
Placebo
Other Name: Sugar pill

Active Comparator: Non-Phobic Control - DCS
Participants without phobia will be given one D-cycloserine (DCS) administration of 100mg.
Drug: D-cycloserine
D-cycloserine
Other Name: Cycloserine

Placebo Comparator: Spider-phobic Placebo
Participants with phobia will be given one placebo administration.
Drug: Placebo
Placebo
Other Name: Sugar pill

Experimental: Spider-phobic DCS
Participants with phobia will be given one D-cycloserine (DCS) administration of 100mg.
Drug: D-cycloserine
D-cycloserine
Other Name: Cycloserine




Primary Outcome Measures :
  1. fMRI Brain Activations During Symptom Provocation [ Time Frame: 2 Weeks ]
    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.


Secondary Outcome Measures :
  1. Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests) [ Time Frame: 2 Weeks ]
    This scale measures the learning and memory of functioning adults. Logical Memory I and II and Faces I and II subtests were administered to participants. The tasks measure verbal and visual memory, respectively. Scoring is based on the number of story details or faces correctly recalled during immediate (Logical Memory I, Faces I) and 30 minute delayed (Logical Memory II, Faces II) conditions. Total score ranges from 0-75 on Logical Memory I, 0-50 on Logical Memory II, 0-48 on Faces I, and 0-48 on Faces II. For all subtests, higher scores indicate better memory performance.

  2. Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT) [ Time Frame: 2 weeks ]
    The RCFT assesses the a person's ability to use cues to retrieve information. The test measures visuospatial construction and memory. A person is asked to draw a figure. The figure is broken down into 18 elements. The score is based on their presence, completeness, and correct placement. Each element is scored from 0-2. The Copy, Immediate, and Delay results are scored on a 36 point scale. The higher the score, the better the person performed on the test with a 0 being the minimum and 36 being the maximum score. The organization score is scored according to whether the participant drew five cohesive units of the figure together, for a range of 0-6 and a higher score indicating better organizational performance.

  3. Cognitive Functioning Measured Using the Iowa Gambling Test [ Time Frame: 2 weeks ]
    This test measures a person's emotional decision making. Participants are presented with virtual decks of cards on a computer. Participants are told that each card they draw will "win" them game money. However, sometimes cards result in "losing" game money. The task includes 100 trials and the total score represents the number of cards drawn from "bad" decks as compared to "good" or safe decks. Thus, the score ranges from -100 to +100, with higher sores representing better performance.

  4. Cognitive Functioning Measured Using the Wisconsin Card Sorting Task [ Time Frame: 2 weeks ]
    The Wisconsin Card Sorting Task measures executive functioning and cognitive flexibility. The task uses a deck of 64 cards that the participant must sort according to specified rules. The test is stopped when when six sequences of 10 correct responses have been achieved, or after the deck has been completed twice, which provides a cumulative total of 128 trials. We report the number of errors on the task, which has a range of 0 -128, with a higher score representing worse performance.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591825


Locations
United States, Kansas
University of Kansas Medical Center, Hoglund Brain Imaging Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
American Psychological Foundation
Nepalese Psychological Association
Investigators
Principal Investigator: Cary Savage, PhD University of Kansas Medical Center

Responsible Party: Cary Savage, Ph.D., Director, CHBN and John H. Wineinger Professor of Psychiatry and Behavioral Sciences, University of Kansas
ClinicalTrials.gov Identifier: NCT00591825     History of Changes
Other Study ID Numbers: 10362
GCRC 0046 ( Other Identifier: University of Kansas Medical Center )
HSCL 15970 ( Other Identifier: University of Kansas )
First Posted: January 11, 2008    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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