Exploring Learning and Unlearning of Fear

NCT01512316 | Withdrawn

• 1 other identifier: IMDCSACQEXT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Individuals

Keywords

Fear; Cycloserine; Conditioning; Functional neuroimaging; Anxiety disorders

Outcome Measures

Primary Outcomes (1)

• change in BOLD-signal during a fear conditioning task

  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

Study Arms (3)

d-Cycloserine Acquisition

ACTIVE COMPARATOR

d-Cycloserine will be given on day1, before acquisition

Drug: d-Cycloserine; Genetic: Saliva sample; Other: Functional neuroimaging (fMRI)

d-Cycloserine Extinction

ACTIVE COMPARATOR

d-Cycloserine will be administered on day2, before extinction

Drug: d-Cycloserine; Genetic: Saliva sample; Other: Functional neuroimaging (fMRI)

Placebo

PLACEBO COMPARATOR

A placebo pill will be administered on day1 and 2

Drug: Lactose pill; Genetic: Saliva sample; Other: Functional neuroimaging (fMRI)

Interventions

d-Cycloserine DRUG

250mg, one dose, 2hrs prior to fMRI

Also known as: Cycloserine, King Pharmaceuticals Ltd

d-Cycloserine Acquisition; d-Cycloserine Extinction

Lactose pill DRUG

one dose, 2hrs prior to fmri

Placebo

Saliva sample GENETIC

Buccal cell material will be sampled from all participants on day3

Also known as: Whatman's Sterile Omni Swabs (www.whatman.com)

Placebo; d-Cycloserine Acquisition; d-Cycloserine Extinction

Functional neuroimaging (fMRI) OTHER

Placebo; d-Cycloserine Acquisition; d-Cycloserine Extinction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Catholic University Leuven, Departement of Radiology

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cycloserine; Lactose; Functional Neuroimaging

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 19, 2012
• Last Updated: January 31, 2023

Record last verified: 2016-05

Locations

BE (1)