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Trial record 64 of 121 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Exploring Learning and Unlearning of Fear

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ClinicalTrials.gov Identifier: NCT01512316
Recruitment Status : Unknown
Verified December 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE December 22, 2011
First Posted Date  ICMJE January 19, 2012
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2012)
change in BOLD-signal during a fear conditioning task [ Time Frame: t0, t+24, t+48 ]
Subjects will participate in a 3-day experiment. Day1 (t0): Acquisition Day2 (T+24): extinction Day3 (T+48): re-exposure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploring Learning and Unlearning of Fear
Official Title  ICMJE The Effect of D-cycloserine on Fear Learning and Extinction
Brief Summary

The present study investigates the effect of d-cycloserine on learning and unlearning of fear in healthy humans and its underlying effect on the amygdala.

As a second objective, the effect of genotype on fear learning will be studied.

Detailed Description

A growing body of evidence suggests that the extinction of fear is mediated by the N-methyl-D-aspartate (NMDA) receptor activity in the basolateral amygdala. Intra-amygdala infusions of antagonists of this glutamate receptor in small animals (eg: rats, mice) have demonstrated a blockage of fear acquisition and extinction. Agonists, on the other hand, facilitate conditioned fear extinction.

The animal studies are all based on the simple fear learning paradigm of conditioning. However, it is not clear that human anxiety disorders are based on prior conditioning encounter. Therefore it is important to disentangle the effect of DCS on acquisition and extinction in the context of a simple learning paradigm, particular its effect on the human amygdala.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Individuals
Intervention  ICMJE
  • Drug: d-Cycloserine
    250mg, one dose, 2hrs prior to fMRI
    Other Name: Cycloserine, King Pharmaceuticals Ltd
  • Drug: Lactose pill
    one dose, 2hrs prior to fmri
  • Genetic: Saliva sample
    Buccal cell material will be sampled from all participants on day3
    Other Name: Whatman's Sterile Omni Swabs (www.whatman.com)
  • Other: Functional neuroimaging (fMRI)
Study Arms  ICMJE
  • Active Comparator: d-Cycloserine Acquisition
    d-Cycloserine will be given on day1, before acquisition
    Interventions:
    • Drug: d-Cycloserine
    • Genetic: Saliva sample
    • Other: Functional neuroimaging (fMRI)
  • Active Comparator: d-Cycloserine Extinction
    d-Cycloserine will be administered on day2, before extinction
    Interventions:
    • Drug: d-Cycloserine
    • Genetic: Saliva sample
    • Other: Functional neuroimaging (fMRI)
  • Placebo Comparator: Placebo
    A placebo pill will be administered on day1 and 2
    Interventions:
    • Drug: Lactose pill
    • Genetic: Saliva sample
    • Other: Functional neuroimaging (fMRI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 13, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No axis I diagnosis compatible with the DSM-IV by means of a structured diagnostic interview
  • Right-handed

Exclusion Criteria:

  • Current psychopharmacological or psychological treatment.
  • The presence of a physical/medical condition that may interfere with the study.
  • A contraindication for the use of DCS
  • Pacemaker, medication pump (such as insulin pump), hearing aid, removable prosthodontics
  • Metal in or on body (such as acupuncture needles, artificial limbs, stents, metal splints, clips, implanted electrodes, tattoos, or piercings)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01512316
Other Study ID Numbers  ICMJE IMDCSACQEXT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP