Clinical Trials in Denmark / NCT04336228
Active, not recruiting
Phase 4
The Role of Serotonin in Compulsive Behavior in Humans: Underlying Brain Mechanisms
NCT04336228 · tracked via the Priya Life Science Denmark tracker
Condition(s) studied
Obsessive-Compulsive Disorder/High Compulsive IndividualsHealthy Individuals
Investigational drug(s) / intervention(s)
Escitalopram →Placebo oral tablet
Escitalopram: 20mg daily for 3-4 weeks.
Placebo oral tablet: 20mg placebo tablet daily for 3-4 weeks.
Study summary
The aim of this project is to investigate:
* 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Current or previous neurological disease, severe somatic disease, or consumption of medical drugs likely to influence the test results
* 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.
* Contraindications for MRI (pacemaker, metal implants, etc.).
* Allergy to the ingredients in the administered drug.
* Abnormal ECG (e.g. prolonged QT syndrome).
* 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).
* Head injury or concussion resulting in loss of consciousness for more than 2 min.
* Alcohol or drug abuse
* Drug use other than tobacco and alcohol within the last 30 days.
* Hash \> 50 x lifetime.
* 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.
* Severe physical impairments affecting eyesight or motor performance.
* 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).
Primary outcome measure(s)
- Learning Primary Outcome 1 measured with Probability Reversal Learning test: Mean errors Stage 1 (Learning) — 3 years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Learning Primary Outcome 2 measured with Probability Reversal Learning test: Mean errors Stage 2 (Reversal) — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Learning Primary Outcome 3 measured with Deterministic Reversal Learning test: Percent correct per stage — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Inhibition Primary Outcome 1 measured with Interleaved Stop Signal Task/Go-NoGo: Stop Signal Reaction Time — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. - Flexibility Primary Outcome 1 measured with 3Dimensional Intra/Extra Dimensional Shift test: Extra Dimensional Set Errors — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. - Flexibility Primary Outcome 2 measured with Sequential model-based model-free test: Model-based Model-free Weight — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. - Social Cognition Primary Outcome 1 measured with EMOTICOM Moral Emotions Task: Agent Guilt Score — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Social Cognition Primary Outcome 2 measured with EMOTICOM Moral Emotions Task: Agent Shame Score — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. The false discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Emotion Recognition Primary Outcome 1 measures with EMOTICOM Intensity Morphing: Affective bias in decreasing condition — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Emotion Recognition Primary Outcome 2 measured with EMOTICOM Emotion Recognition Task: Affective bias for D' — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Emotion Recognition Primary Outcome 3 measured with EMOTICOM Intensity Morphing task: Detection threshold decreasing — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Emotion Recognition Primary Outcome 4 measured with EMOTICOM Emotion Recognition task: D'Prime for emotion recognition — 3 Years
Emotion Recognition Task. Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Memory Primary Outcome 1 measured with CANTAB Paired Associates Learning: Total Errors Adj — 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. False discovery rate (FDR) correction, for multiple comparisons, using the Benjamini-Hochberg procedure will be applied to the outcomes within each cognitive domain. - Biofluids — 3 Years
Serum Escitalopram levels - Positron emission tomography (PET) Imaging: Cerebral [11C]SB207145 PET binding. — 3 Years
Collected before and after participant's intervention. - Neural Activations and Correlations measured with functional magnetic resonance imaging (fMRI) paradigm named Slip of Actions — 3 Years
Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12. - Neural Activations and Correlations measured with functional magnetic resonance imaging (fMRI) paradigm named Cohabit — 3 Years
Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12Co-habit fMRI paradigm Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12. - Neural Activations and Correlations measured with functional magnetic resonance imaging (fMRI) paradigm named Faces — 3 Years
Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12. - Resting State fMRI — 3 Years
Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12. - Structural Voxel-based morphometry (VBM) MRI — 3 Years
Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12. - Diffusion Tensor Imaging MRI — 3 Years
- Habit formation outcome 1: response times for each day of training — 3 Years
Daily app training paradigm - Habit formation outcome 2: mean errors per sequence and moves — 3 Years
Daily app training paradigm - Habit formation outcome 3: confidence and enjoyable rates. — 3 Years
Daily app training paradigm
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Neurobiology Research Unit, Rigshospitalet | Copenhagen | Denmark |
On this site
📄 Lexapro (escitalopram) drug profile →More Copenhagen University Hospital, Rigshospitalet trials in Denmark
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04336228 on ClinicalTrials.gov ↗ ← All trials in Denmark