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The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear Healthy Controls. (DCS)

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ClinicalTrials.gov Identifier: NCT01733030
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

PROJECT SUMMARY:

PTSD is a debilitating psychiatric condition precipitated by exposure to extreme, or life threatening, trauma with an estimated lifetime prevalence between 8% and 9% in U.S. adults. One core symptom of PTSD is intense psychological distress in the presence of stimuli that "resemble" one or more aspects of the trauma experience (DSM-IV). This phenomenon referred to as stimulus generalization has received surprisingly little empirical testing in the context of clinical anxiety in general, and PTSD more specifically. The current proposal represents the first effort to study the neurobiology and pharmacology of this PTSD-relevant learning phenomenon across those with and without PTSD. The objective of this particular proposal is to apply fMRI and pharmacologic methods to: 1) identify brain mechanisms associated with generalization of conditioned fear and 2) examine the pharmacologic modifiability of levels of generalization using a partial agonist at the NMDA receptor complex (D-cycloserine) shown to increase discrimination of CS+ (danger cue) and CS- (safety cue) in animal studies.


Condition or disease Intervention/treatment
Post Traumatic Stress Syndrome Drug: Seromycin

Detailed Description:
To fullfill the objectives of this application, a generalization paradigm has been designed and psychophysiologically validated in which 6 rings presented on a computer screen gradually increase in size. For half of participants the smallest ring is the conditioned stimulus paired with electric shock (CS+) and the largest is the unpaired stimulus (CS-), and for the other half of participants this is reversed. Activity in fear-related brain structures measured via fMRI are predicted to gradually decrease as the presented stimulus gradually becomes less similar to the CS+, forming a generalization slope or gradient. One central hypothesis of the current application is that DCS (Seromycin) will dose dependently increase the steepness of generalization gradients (i.e., reduce fear generalization). This study will include 3 groups of healthy adults recieving either 1) 500 mg Seromycin, 2) 250 mg Seromycin, or placebo only prior to acquisition of fear conditioning. Twenty four hours later, participants will return to complete an fMRI during which brain responses to the danger cue and stimuli resembling the danger cue will be assessed.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear in Healthy Controls.
Study Start Date : January 2013
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Group/Cohort Intervention/treatment
250 mg Seromycin
Healthy adults who will receeve one administration of 250 mg of Seromycin prior to the start of the study.
Drug: Seromycin
250 mg versus 500 mg versus placebo effects on conditioned fear generalization
Other Name: D-cycloserine

Drug: Seromycin
500 mg Seromycin
Healthy adults who will recieve one administration of 500 mg of Seromycin prior to the start of the study.
Drug: Seromycin
250 mg versus 500 mg versus placebo effects on conditioned fear generalization
Other Name: D-cycloserine

Drug: Seromycin
Placebo
Healthy adults who will receive one administration of a placebo pill prior to the start of the study.



Primary Outcome Measures :
  1. fMRI (BOLD) responses [ Time Frame: 1/1/13-6/1/14 ]
    fMRI (BOLD) responses


Secondary Outcome Measures :
  1. Behavioral assessments of perceived danger [ Time Frame: up to three years ]
    Behavioral assessments of perceived danger



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adults between the ages of 18-55.
Criteria

Inclusion Criteria:

  • Healthy adults between the ages of 18-55.

Exclusion Criteria:

  1. Current or past Axis I psychiatric diagnosis as determined by self report
  2. Current substance dependence or meet criteria for the six month period preceding testing.
  3. Participants will be excluded if they have current or past medical illnesses, which place the participant at risk or confound the results of the study including:

    A) Past history of hypersensitivity to Seromycin B) Current or past epileptic disorders C) Current depression D) Current anxiety disorders E) Current or past psychotic disorders F) Current or past renal disease G) Excessive or concurrent use of alcohol

    a) Subjects who are unable to abstain from alcohol for 12 hours prior to testing and 2 days following testing will be excluded

  4. Current use of psychoactive medications or medications that alter central-nervous-system function
  5. Females who are pregnant or currently breast-feeding
  6. Any metallic implants or objects above the knee, tattoos about the knee, or oral braces.

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): NCT01733030


Locations
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United States, Minnesota
University of MInnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Shmuel Lissek, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01733030    
Other Study ID Numbers: MH080130
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by University of Minnesota:
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action