Exploring Learning and Unlearning of Fear

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01512316
First received: December 22, 2011
Last updated: January 13, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention
Healthy Individuals
Drug: d-Cycloserine
Drug: Lactose pill
Genetic: Saliva sample
Other: Functional neuroimaging (fMRI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of D-cycloserine on Fear Learning and Extinction

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • change in BOLD-signal during a fear conditioning task [ Time Frame: t0, t+24, t+48 ] [ Designated as safety issue: No ]
    Subjects will participate in a 3-day experiment. Day1 (t0): Acquisition Day2 (T+24): extinction Day3 (T+48): re-exposure


Estimated Enrollment: 90
Arms Assigned Interventions
Active Comparator: d-Cycloserine Acquisition
d-Cycloserine will be given on day1, before acquisition
Drug: d-Cycloserine
250mg, one dose, 2hrs prior to fMRI
Other Name: Cycloserine, King Pharmaceuticals Ltd
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)
Active Comparator: d-Cycloserine Extinction
d-Cycloserine will be administered on day2, before extinction
Drug: d-Cycloserine
250mg, one dose, 2hrs prior to fMRI
Other Name: Cycloserine, King Pharmaceuticals Ltd
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)
Placebo Comparator: Placebo
A placebo pill will be administered on day1 and 2
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512316

Contacts
Contact: Liesbet Goossens, PhD +31 43 3685306 lies.goossens@maastrichtuniversity.nl
Contact: Stefan Sunaert, MD PhD +32 16 349021 stefan.sunaert@uz.kuleuven.be

Locations
Belgium
Catholic University Leuven, Departement of Radiology Not yet recruiting
Leuven, Belgium, 3000
Contact: Stefan Sunaert, MD PhD    +32 16 349021    stefan.sunaert@uz.kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01512316     History of Changes
Other Study ID Numbers: IMDCSACQEXT
Study First Received: December 22, 2011
Last Updated: January 13, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Fear
Cycloserine
Conditioning
Functional neuroimaging
Anxiety disorders

Additional relevant MeSH terms:
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014