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NCT Number: NCT04336228

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neurobiology Research Unit, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

Previous studies have shown that 5-HT is strongly implicated in compulsive behaviours in experimental animals. Manipulation of 5-HT influences neuronal interactions underlying action selection. Reduced forebrain 5-HT causes perseveration and impairs goal-directed behaviour under reward but not punishment. Dysfunctional 5-HT neurotransmission has also been implicated in Obsessive-Compulsive Disorder (OCD) based on the selective efficacy of relatively high doses of selective serotonin reuptake inhibitors (SSRIs) in treating this disorder. Hitherto, it is unknown whether there is a primary defect in the serotonergic system or whether SSRIs ameliorate symptoms by modulating other brain neurotransmitter pathways. So far, only one study of central 5-HT release in OCD patients has been conducted and its methodology may be questioned.

A number of behavioural and cognitive features of OCD, including endophenotype markers that appear to characterise the disorder have been determined. These include a shift in cognitive control from a goal-directed strategy to a habitual (stimulus-response, S-R) strategy, cognitive rigidity in terms of both reversal learning and attentional set-shifting, impaired response inhibition and planning, and a tendency to over-respond to spurious negative feedback in a probabilistic learning paradigm. Neural substrates of these deficits are being investigated using brain imaging methodologies based on magnetic resonance and preliminary evidence suggests an over-active medial prefrontal cortex-caudate nucleus circuits and underactive lateral prefrontal cortex-putamen circuits. However, little evidence exists that relates to the hypothesis of an over-active habit system in this disorder or to the role of serotonin in all these cognitive and behavioural deficits observed in OCD and compulsivity in general.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Escitalopram

Drug

20mg daily for 3-4 weeks.

Other names: Escitalopram STADA

Placebo oral tablet

Drug

20mg placebo tablet daily for 3-4 weeks.

Other names: calcium tables

Primary outcomes

  1. Learning Primary Outcome 1 measured with Probability Reversal Learning test: Mean errors Stage 1 (Learning)

    Time frame: 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.

  2. Learning Primary Outcome 2 measured with Probability Reversal Learning test: Mean errors Stage 2 (Reversal)

    Time frame: 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.

  3. Learning Primary Outcome 3 measured with Deterministic Reversal Learning test: Percent correct per stage

    Time frame: 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.

  4. Inhibition Primary Outcome 1 measured with Interleaved Stop Signal Task/Go-NoGo: Stop Signal Reaction Time

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  5. Flexibility Primary Outcome 1 measured with 3Dimensional Intra/Extra Dimensional Shift test: Extra Dimensional Set Errors

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  6. Flexibility Primary Outcome 2 measured with Sequential model-based model-free test: Model-based Model-free Weight

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  7. Social Cognition Primary Outcome 1 measured with EMOTICOM Moral Emotions Task: Agent Guilt Score

    Time frame: 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.

  8. Social Cognition Primary Outcome 2 measured with EMOTICOM Moral Emotions Task: Agent Shame Score

    Time frame: 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.

  9. Emotion Recognition Primary Outcome 1 measures with EMOTICOM Intensity Morphing: Affective bias in decreasing condition

    Time frame: 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.

  10. Emotion Recognition Primary Outcome 2 measured with EMOTICOM Emotion Recognition Task: Affective bias for D'

    Time frame: 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.

  11. Emotion Recognition Primary Outcome 3 measured with EMOTICOM Intensity Morphing task: Detection threshold decreasing

    Time frame: 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.

  12. Emotion Recognition Primary Outcome 4 measured with EMOTICOM Emotion Recognition task: D'Prime for emotion recognition

    Time frame: 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.

  13. Memory Primary Outcome 1 measured with CANTAB Paired Associates Learning: Total Errors Adj

    Time frame: 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.

  14. Biofluids

    Time frame: 3 Years

    Serum Escitalopram levels

  15. Positron emission tomography (PET) Imaging: Cerebral [11C]SB207145 PET binding.

    Time frame: 3 Years

    Collected before and after participant's intervention.

  16. Neural Activations and Correlations measured with functional magnetic resonance imaging (fMRI) paradigm named Slip of Actions

    Time frame: 3 Years

    Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12.

  17. Neural Activations and Correlations measured with functional magnetic resonance imaging (fMRI) paradigm named Cohabit

    Time frame: 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.

  18. Neural Activations and Correlations measured with functional magnetic resonance imaging (fMRI) paradigm named Faces

    Time frame: 3 Years

    Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12.

  19. Resting State fMRI

    Time frame: 3 Years

    Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12.

  20. Structural Voxel-based morphometry (VBM) MRI

    Time frame: 3 Years

    Imaging outcomes will be Family-Wise Error (FWE) corrected using Random Field Theory as implemented in SPM12.

  21. Diffusion Tensor Imaging MRI

    Time frame: 3 Years

  22. Habit formation outcome 1: response times for each day of training

    Time frame: 3 Years

    Daily app training paradigm

  23. Habit formation outcome 2: mean errors per sequence and moves

    Time frame: 3 Years

    Daily app training paradigm

  24. Habit formation outcome 3: confidence and enjoyable rates.

    Time frame: 3 Years

    Daily app training paradigm

Secondary outcomes

  1. Learning Secondary Outcome 1 measured with Probability Reversal Learning test: Stage 1 Reward-Stay/Lose-Shift behaviour

    Time frame: 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.

  2. Learning Secondary Outcome 2 measured with Probability Reversal Learning test: Stage 1 Reward/Punishment learning

    Time frame: 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.

  3. Learning Secondary Outcome 3 measured with Probability Reversal Learning test: Stage 1. Stimulus Stickiness

    Time frame: 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.

  4. Learning Secondary Outcome 4 measured with Probability Reversal Learning test: Stage 2 Reward-Stay/ Lose-Shift behaviour

    Time frame: 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.

  5. Learning Secondary Outcome 5 measured with Probability Reversal Learning test: Stage 2 Reward/Punishment learning

    Time frame: 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.

  6. Learning Secondary Outcome 6 measured with Probability Reversal Learning test: Stage 2. Stimulus Stickiness

    Time frame: 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.

  7. Learning Secondary Outcome 7 measured with Deterministic Reversal Learning test: Reward-Stay/ Lose-Shift behaviour

    Time frame: 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.

  8. Flexibility Secondary Outcome 1 measured with Sequential Model-Based/Model-Free test: Proportion of Stays

    Time frame: 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.

  9. Flexibility Secondary Outcome 2 measured with Sequential Model-Based/Model-Free test: Exploration

    Time frame: 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.

  10. Flexibility Secondary Outcome 3 measured with Sequential Model-Based/Model-Free test: Stimulus Stickiness

    Time frame: 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.

  11. Flexibility Secondary Outcome 4 measured with Sequential Model-Based/Model-Free test: Learning rate

    Time frame: 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.

  12. Flexibility Secondary Outcome 5 measured with 3Dimensional Intra/Extra Dimensional Shift test: Pre Extra Dimension Set Errors

    Time frame: 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.

  13. Flexibility Secondary Outcome 6 measured with 3Dimensional Intra/Extra Dimensional Shift test: Latency

    Time frame: 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.

  14. Inhibition Secondary Outcome 1 measured with Interleaved Stop Signal Task/Go-NoGo: Go reaction time

    Time frame: 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.

  15. Inhibition Secondary Outcome 2 measured with Interleaved Stop Signal Task/Go-NoGo: Go omission error rate

    Time frame: 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.

  16. Inhibition Secondary Outcome 3 measured with Interleaved Stop Signal Task/Go-NoGo: Go commission error rate

    Time frame: 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.

  17. Inhibition Secondary Outcome 4 measured with Interleaved Stop Signal Task/Go-NoGo: No-Go error rate

    Time frame: 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.

  18. Executive Function Secondary Outcome 1 measured with 3Dimensional Intra/Extra Dimensional Shift test: Total Errors Adjusted

    Time frame: 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.

  19. Emotion Recognition Secondary Outcome 1 measured with EMOTICOM Intensity Morphing Task: Detection threshold increasing

    Time frame: 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.

  20. Emotion Recognition Secondary Outcome 2 measured with EMOTICOM Intensity Morphing Task: Affective bias in increasing condition

    Time frame: 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.

  21. Emotion Recognition Secondary Outcome 3 measured with EMOTICOM Emotion Recognition Task: Affective bias for Hit Rate

    Time frame: 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.

  22. Emotion Recognition Secondary Outcome 4 measured with EMOTICOM Emotion Recognition Task.: Hit Rate for Emotion Recognition

    Time frame: 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.

  23. Faces and geometric figure discrimination Outcome 1 measured with fMRI faces paradigm: Accuracy

    Time frame: 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.

  24. Behavioural outcomes with Faces and geometric figure discrimination Outcome 2 measured with fMRI faces paradigm: Response Speed

    Time frame: 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.

  25. Behavioural outcomes with fMRI paradigm slip of Actions : accuracy and latency

    Time frame: 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.

  26. Behavioural outcomes with fMRI paradigm Co-habit: accuracy and latency.

    Time frame: 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.

  27. Memory Outcome 1 measured with CANTAB Paired Associates Learning test: First Trial Memory Score

    Time frame: 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.

  28. Memory Outcome 2 measured with Letter-number sequencing test: Total score

    Time frame: 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.

  29. Memory Primary outcome 3 measured with Verbal Affective Memory Test-26: Latent variable model of the association between positive, negative and neutral word recall and 5-HT4R binding

    Time frame: 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.

  30. Risky Decision Making Outcome Outcome 1 measured with EMOTICOM Cambridge Gamble Task: Quality of Decision Making

    Time frame: 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.

  31. Risky Decision Making Outcome 2 measured with EMOTICOM Cambridge Gamble Task: Risk Adjustment

    Time frame: 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.

  32. Risky Decision Making Outcome 3 measured with EMOTICOM Cambridge Gamble Task: Overall Proportion Bet

    Time frame: 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.

  33. Risky Decision Making Outcome 4 measured with EMOTICOM Cambridge Gamble Task: Deliberation Time

    Time frame: 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.

  34. Psychomotor Speed Outcome 1 measured with CANTAB Reaction Time Task: Simple reaction time

    Time frame: 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.

  35. Intelligence Quotient (IQ) outcome 1 measured with Reynolds Intellectual assessment Scales subtest "guess what" and "what does not fit": Total age adjusted score

    Time frame: 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

  36. Interpersonal Reactivity Index (IRI) Score

    Time frame: 3 Years

  37. Obsessive- Compulsive Inventory (OCI)- state Score

    Time frame: 3 Years

  38. Obsessive- Compulsive Inventory- trait Score

    Time frame: 3 Years

  39. Brief Symptom Inventory (BSI) Score

    Time frame: 3 Years

  40. Pittsburgh Sleep Quality Index Score

    Time frame: 3 Years

  41. Profile of Mood State Score

    Time frame: 3 Years

  42. Beck Depression Inventory-II Score

    Time frame: 3 Years

    Contain 21-items, scored on a scale value of 0 to 3

  43. State-Trait Anxiety Inventory Scale Score

    Time frame: 3 Years

    Contain 40-items

  44. State and Trait Aggression Questionnaire Score

    Time frame: 3 Years

  45. Barratt Impulsiveness Scale-State Score

    Time frame: 3 Years

  46. Visual Analogue Scale Score

    Time frame: 3 Years

Other outcomes

  1. Emotion Recognition Other Outcome 1: Detection threshold decreasing Happy - Intensity Morphing

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  2. Emotion Recognition Other Outcome 2: Detection threshold decreasing Sad - Intensity Morphing

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  3. Emotion Recognition Other Outcome 3: Detection threshold decreasing Anger - Intensity Morphing

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  4. Emotion Recognition Other Outcome 4: Detection threshold decreasing Fear - Intensity Morphing

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  5. Emotion Recognition Other Outcome 5: Detection threshold decreasing Disgust - Intensity Morphing

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  6. Emotion Recognition Other Outcome 6: D' Happy - Emotion Recognition Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  7. Emotion Recognition Other Outcome 7: D' Sad - Emotion Recognition Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  8. Emotion Recognition Other Outcome 8: D' Fear - Emotion Recognition Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  9. Emotion Recognition Other Outcome 9: D' Anger - Emotion Recognition Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains.

  10. Activity Level Score

    Time frame: 3 Years

  11. Behavioural Inhibition/ Behavioural Avoidance Scale Score

    Time frame: 3 Years

  12. The Compulsive Personality Assessment Scale Score

    Time frame: 3 Years

  13. Sexuality Questionnaire Score

    Time frame: 3 Years

  14. Edinburgh Handedness Inventory Score

    Time frame: 3 Years

  15. Revised NEO Personality Questionnaire Score

    Time frame: 3 Years

  16. Family History Assessment Module Score

    Time frame: 3 Years

  17. Positive Life Events Score

    Time frame: 3 Years

  18. Stressful Life Events Score

    Time frame: 3 Years

  19. Perceived stress scale

    Time frame: 3 Years

  20. Barratt Impulsiveness Scale-Trait Score

    Time frame: 3 Years

  21. The Penn State Worry Questionnaire- Trait Score

    Time frame: 3 Years

  22. The Penn State Worry Questionnaire- State Score

    Time frame: 3 Years

  23. The Self-Control Scale- Trait Score

    Time frame: 3 Years

  24. The Self-Control Scale- State Score

    Time frame: 3 Years

  25. State- Trait Anxiety Inventory- Trait Score

    Time frame: 3 Years

  26. The Warwick-Edinburgh Mental Well-being Scale -State Score

    Time frame: 3 Years

  27. The Warwick-Edinburgh Mental Well-being Scale -Trait Score

    Time frame: 3 Years

  28. Mindful Attention and Awareness Scale -State Score

    Time frame: 3 Years

  29. Mindful Attention and Awareness Scale -Trait Score

    Time frame: 3 Years

  30. The Intolerance of Uncertainty Scale - Trait Score

    Time frame: 3 Years

  31. The Intolerance of Uncertainty Scale - State Score

    Time frame: 3 Years

  32. Verran and Snyder-Halpern (VSH) Sleep Scale Score

    Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Lundbeck Foundation
  • University of Cambridge

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2020
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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