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Active, not recruitingPhase 4

The Role of Serotonin in Compulsive Behavior in Humans: Underlying Brain Mechanisms

Key facts

Who runs it
Copenhagen University Hospital, Rigshospitalet
Where
Denmark1 site in 1 countryChoose a country to see its sites
Trial code
Status
Active, not recruiting
Phase
Phase 4
People taking part
46 people enrolled
Started
1 Apr 2020
Expected to end
31 Dec 2027
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Escitalopram
  • Placebo oral tablet
Record updated
18 December 2024

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • Individuals with high scores on obsessive-compulsive traits (with or without a diagnosis of OCD established by a psychiatrist) and healthy volunteers (male or female) between 18 and 70 years. Compulsive individuals without an OCD diagnosis are individuals without a history of psychiatric or other major medical conditions but scoring abnormally high on the Obsessive-Compulsive Inventory (OCI) questionnaire

Who cannot take part

  • Current or previous neurological disease, severe somatic disease, or consumption of medical drugs likely to influence the test results
  • Contraindications for MRI (pacemaker, metal implants, etc.)
  • Alcohol or drug abuse
  • Drug use other than tobacco and alcohol within the last 30 days
  • Drugs > 10 x lifetime (for each substance)
  • Current medication with serotonergic acting compounds. Use of other psychoactive substances must be stable at least one month prior to inclusion and maintained throughout the study
  • Allergy to the ingredients in the administered drug
  • Dizzy when changing from supine to upright position (e.g. postural orthostatic tachycardia syndrome)
  • Mild hypotension (blood pressure below 100/70 mmHg) or hypertension (blood pressure above 140/90 mmHg)
  • For the OCD group: other Axis I mental disorder as primary diagnosis according to ICD-10 criteria
  • For healthy volunteers: any current or former primary psychiatric disorder (Axis I WHO ICD-10 diagnostic classification)
  • Abnormal ECG (e.g. prolonged QT syndrome)
  • Non- fluent in Danish or pronounced visual or auditory impairments
  • Current or past learning disability
  • Pregnancy
  • Lactation
  • Participation in experiments with radioactivity (> 10 mSv) within the last year or significant occupational exposure to radioactivity
  • Head injury or concussion resulting in loss of consciousness for more than 2 min
  • Hash > 50 x lifetime
  • Severe physical impairments affecting eyesight or motor performance

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The aim of this project is to investigate:

Read full original descriptionShow less

* The status of the central serotonin (5-hydroxytryptamine, 5-HT) system in compulsive behaviour and how it is affected by sub-chronic escitalopram administration * The mechanisms underlying how sub-chronic administration of escitalopram affects the central 5-HT system * How changes in cognitive performance, including the balance between habitual and goal-directed mechanisms, are affected in compulsive behaviour by boosting 5-HT function * How functional brain changes in cognitive function measured with magnetic resonance imaging relate to altered 5-HT function following escitalopram administration.

The 4 groups in the trial

  • Healthy Control GroupPlacebo, for comparison

    The healthy placebo control group will be administered the exact same procedure as the intervention group, the only difference being that this group will be administered a placebo tablet.

    Treatment: Placebo oral tablet

  • Obsessive-Compulsive Disorder / High Compulsivity Control GroupPlacebo, for comparison

    The OCD/high compulsivity placebo control group will be administered the exact same procedure as the intervention group, the only difference being that this group will be administered a placebo tablet.

    Treatment: Placebo oral tablet

  • Healthy Intervention GroupTreatment being tested

    The healthy intervention group will be administered 20mg of Escitalopram daily for 3-4 weeks.

    Treatment: Escitalopram

  • Obsessive-Compulsive Disorder / High Compulsivity Intervention GroupTreatment being tested

    The OCD/high compulsivity intervention group will be administered 20mg of Escitalopram daily for 3-4 weeks.

    Treatment: Escitalopram

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
18 December 2024