Exploring Learning and Unlearning of Fear

NCT ID: NCT01512316

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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d-Cycloserine Acquisition

d-Cycloserine will be given on day1, before acquisition

Group Type ACTIVE_COMPARATOR

d-Cycloserine

Intervention Type DRUG

250mg, one dose, 2hrs prior to fMRI

Saliva sample

Intervention Type GENETIC

Buccal cell material will be sampled from all participants on day3

Functional neuroimaging (fMRI)

Intervention Type OTHER

d-Cycloserine Extinction

d-Cycloserine will be administered on day2, before extinction

Group Type ACTIVE_COMPARATOR

d-Cycloserine

Intervention Type DRUG

250mg, one dose, 2hrs prior to fMRI

Saliva sample

Intervention Type GENETIC

Buccal cell material will be sampled from all participants on day3

Functional neuroimaging (fMRI)

Intervention Type OTHER

Placebo

A placebo pill will be administered on day1 and 2

Group Type PLACEBO_COMPARATOR

Lactose pill

Intervention Type DRUG

one dose, 2hrs prior to fmri

Saliva sample

Intervention Type GENETIC

Buccal cell material will be sampled from all participants on day3

Functional neuroimaging (fMRI)

Intervention Type OTHER

Interventions

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d-Cycloserine

250mg, one dose, 2hrs prior to fMRI

Intervention Type DRUG

Lactose pill

one dose, 2hrs prior to fmri

Intervention Type DRUG

Saliva sample

Buccal cell material will be sampled from all participants on day3

Intervention Type GENETIC

Functional neuroimaging (fMRI)

Intervention Type OTHER

Other Intervention Names

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Cycloserine, King Pharmaceuticals Ltd Whatman's Sterile Omni Swabs (www.whatman.com)

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Catholic University Leuven, Departement of Radiology

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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IMDCSACQEXT

Identifier Type: -

Identifier Source: org_study_id

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