Healthy IndividualsNCT01512316
Exploring Learning and Unlearning of Fear
A study testing d-Cycloserine, Lactose pill and Saliva sample in people with Healthy Individuals, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- d-Cycloserine, Lactose pill and Saliva sample
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No axis I diagnosis compatible with the DSM-IV by means of a structured diagnostic interview
- Right-handed
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Catholic University Leuven, Departement of Radiology
Leuven, 3000
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Individuals
- Being tested
- d-Cycloserine, Lactose pill, Saliva sample, Functional neuroimaging (fMRI)
- Keywords
- Fear, Cycloserine, Conditioning, Functional neuroimaging, Anxiety disorders
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-CycloserineDrug
Also called Cycloserine, King Pharmaceuticals Ltd
250mg, one dose, 2hrs prior to fMRI
Lactose pillDrug
one dose, 2hrs prior to fmri
Saliva sampleGenetic
Also called Whatman's Sterile Omni Swabs (www.whatman.com)
Buccal cell material will be sampled from all participants on day3
Functional neuroimaging (fMRI)Other
| Study group | Role | What they receive |
|---|---|---|
| d-Cycloserine Acquisition | Active comparator | d-Cycloserine will be given on day1, before acquisition Receives: Drug: d-Cycloserine; Genetic: Saliva sample; Other: Functional neuroimaging (fMRI) |
| d-Cycloserine Extinction | Active comparator | d-Cycloserine will be administered on day2, before extinction Receives: Drug: d-Cycloserine; Genetic: Saliva sample; Other: Functional neuroimaging (fMRI) |
| Placebo | Placebo comparator | A placebo pill will be administered on day1 and 2 Receives: Drug: Lactose pill; Genetic: Saliva sample; Other: Functional neuroimaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: t0, t+24, t+48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
Why it stopped: Study was cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512316
- Sponsor's protocol ID
- IMDCSACQEXT
- Status last verified
- May 2016
- First submitted
- 22 Dec 2011
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of D-cycloserine on Fear Learning and Extinction
- ClinicalTrials.gov ID
- NCT01512316
- Acronym / sponsor ID
- IMDCSACQEXT
- Conditions
- Healthy Individuals
- Keywords
- Fear, Cycloserine, Conditioning, Functional neuroimaging, Anxiety disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| d-Cycloserine Acquisition | Active comparator | Drug: d-Cycloserine, Genetic: Saliva sample, Other: Functional neuroimaging (fMRI)d-Cycloserine will be given on day1, before acquisition |
| d-Cycloserine Extinction | Active comparator | Drug: d-Cycloserine, Genetic: Saliva sample, Other: Functional neuroimaging (fMRI)d-Cycloserine will be administered on day2, before extinction |
| Placebo | Placebo comparator | Drug: Lactose pill, Genetic: Saliva sample, Other: Functional neuroimaging (fMRI)A placebo pill will be administered on day1 and 2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No axis I diagnosis compatible with the DSM-IV by means of a structured diagnostic interview
- Right-handed
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| d-CycloserineAlso: Cycloserine, King Pharmaceuticals Ltd250mg, one dose, 2hrs prior to fMRI | Drug | d-Cycloserine Acquisition, d-Cycloserine Extinction |
| Lactose pillone dose, 2hrs prior to fmri | Drug | Placebo |
| Saliva sampleAlso: Whatman's Sterile Omni Swabs (www.whatman.com)Buccal cell material will be sampled from all participants on day3 | Genetic | Placebo, d-Cycloserine Acquisition, d-Cycloserine Extinction |
| Functional neuroimaging (fMRI) | Other | Placebo, d-Cycloserine Acquisition, d-Cycloserine Extinction |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing d-Cycloserine, Lactose pill and Saliva sample in people with Healthy Individuals, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in BOLD-signal during a fear conditioning task (time frame: t0, t+24, t+48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.