Exploring Learning and Unlearning of Fear

January 27, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

The Effect of D-cycloserine on Fear Learning and Extinction

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Catholic University Leuven, Departement of Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cycloserine, King Pharmaceuticals Ltd
Genetic: Saliva sample
Buccal cell material will be sampled from all participants on day3
Other Names:
  • 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 Names:
  • Cycloserine, King Pharmaceuticals Ltd
Genetic: Saliva sample
Buccal cell material will be sampled from all participants on day3
Other Names:
  • 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
Genetic: Saliva sample
Buccal cell material will be sampled from all participants on day3
Other Names:
  • Whatman's Sterile Omni Swabs (www.whatman.com)
Other: Functional neuroimaging (fMRI)
Drug: Lactose pill
one dose, 2hrs prior to fmri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
t0, t+24, t+48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

January 13, 2012

First Posted (ESTIMATE)

January 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMDCSACQEXT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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