Skip to main content
OpenTrials
Completed

NCT Number: NCT04239339

Serotonergic Modulation of Cognition, Emotion and Brain Activation in Healthy Volunteers

The aim of this project is:

* To apply a pharmacological tool of selective serotonin (5-hydroxytryptamine, 5-HT system) reuptake inhibition in healthy humans. Specifically: * To investigate how sub-chronic administration of 20 mg of escitalopram affects cognitive performance ('cold' cognition) and social-emotional functioning ('hot' cognition) compared with placebo; and * To investigate how sub-chronic administration of 20 mg of escitalopram affects functional brain activation during a paradigm of reinforcement learning following drug administration compared with placebo, and how activation relates to cognitive performance and social-emotional functioning.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neurobiology Research Unit

Copenhagen, DK-2100, Denmark

About this study

The aim of this project is:

  • To apply a pharmacological tool of selective serotonin (5-hydroxytryptamine, 5-HT system) reuptake inhibition in healthy humans. Specifically:
  • To investigate how sub-chronic administration of 20 mg of escitalopram affects cognitive performance ('cold' cognition) and social-emotional functioning ('hot' cognition) compared with placebo; and
  • To investigate how sub-chronic administration of 20 mg of escitalopram affects functional brain activation during a paradigm of reinforcement learning following drug administration compared with placebo, and how activation relates to cognitive performance and social-emotional functioning.

Serotonin is a monoamine neurotransmitter implicated in diverse cognitive and affective brain functions. Serotonin has a significant role in the regulation of cognition and mood, including emotional appraisal, perception and flexible behaviour, with 5-HT receptors found in the cortex, amygdala and hippocampus. The investigators have previously shown that in healthy human experimental studies, acute dietary tryptophan depletion induces 'waiting' impulsivity and impulsive behaviours, impairs goal-directed behaviour and shifts behavioural control toward habitual responding when appetitive, but goal-directed when aversive. Reduced availability of forebrain serotonin has also shown to impair a range of cognitive processes, such as psychomotor processing, episodic memory, attention and executive function. Recently, the research team have shown that using an acute and clinically relevant dose (20 mg) of escitalopram impaired learning and cognitive flexibility, but improved response inhibition in healthy humans, suggesting a dissociation of effects possibly mediated by differential modulation of brain serotonin levels in distinct functional neural circuits.

The investigators now aim to investigate the effects of sub-chronic administration of 20 mg of escitalopram (i.e. three weeks) in healthy volunteers using sophisticated neuropsychological testing (Cambridge Neuropsychological Test Automated Battery and EMOTICOM) and functional magnetic resonance imaging (fMRI). Whereas 'cold' cognition refers to the use of non-emotional processing (e.g. episodic memory; spatial working memory), 'hot' cognition is emotion-laden and used in response to stimuli with affective salience (e.g. decision-making under high levels of risk of uncertainty). It has been suggested that cognitive-emotional effects, such as the re-appraisal and re-evaluation of emotions underlying learning mechanisms, may mediate improvements in mood associated with SSRI treatment. This project will help further the understanding of the role of serotonin in the regulation of cognitive and emotional processes, as well the neural correlates underlying reinforcement learning, in healthy humans.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteer (male or female) between 18 and 45 years.

Exclusion criteria

  • Current or former primary psychiatric disorder (DSM IV Axis I or WHO ICD-10 diagnostic classification).
  • Current or previous neurological disease, severe somatic disease, or the consumption of drugs likely to influence the test results.
  • Non- fluent in Danish or pronounced visual or auditory impairments.
  • Current or past learning disability.
  • Pregnancy (females).
  • Lactation (females).
  • 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).
  • Nicotine addiction.
  • Current psychoactive medication.
  • Severe physical impairments affecting eyesight or motor performance.
  • Hamilton-6 depression scale score > 5.

Treatment and study plan

Escitalopram 20 mg

Drug

20mg daily for approximately 3 weeks.

Placebo

Drug

Placebo daily for approximately 3 weeks.

Primary outcomes

  1. Learning Primary Outcome 1: Mean errors Stage 1 (Learning) - Probability Reversal Learning.

    Time frame: 3 years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  2. Learning Primary Outcome 2: Mean errors Stage 2 (Reversal) - Probability Reversal Learning.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  3. Learning Primary Outcome 3: Learning Rate in Reward Trial - Reinforcement Learning.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  4. Learning Primary Outcome 4: Learning Rate in Punishment Trials - Reinforcement Learning.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

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

    Time frame: 3 Years

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

  6. Executive Function Primary Outcome 1: Extra Dimensional Set Errors -3Dimensional Intra/Extra Dimensional Shift.

    Time frame: 3 Years

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

  7. Reinforcement Behaviour Model

    Time frame: 3 Years

    A model comparison will be conducted to determine the winning model of reinforcement behaviour using one, a combination of, or all these parameters. The winning model will be a single outcome model.

    • Reward Learning Rate
    • Punishment Learning Rate
    • Reinforcement Sensitivity
    • Stimulus Stickiness

  8. Social Cognition Primary Outcome 1: Proportion of offers accepted - Ultimatum Game

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  9. Social Cognition Primary Outcome 2: Agent Guilt Score - Moral Emotions Task.

    Time frame: 3 Years

    • Agent Shame Score ---------- Moral Emotions Task Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  10. Social Cognition Primary Outcome 3: Agent Shame Score - Moral Emotions Task.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  11. Emotion Recognition Primary Outcome 1: Affective bias in decreasing condition - EMOTICOM Intensity Morphing.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  12. Emotion Recognition Primary Outcome 2: Affective bias for D' - EMOTICOM Emotion Recognition Task.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  13. Emotion Recognition Primary Outcome 3: Detection threshold decreasing - EMOTICOM Intensity Morphing.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  14. Emotion Recognition Primary Outcome 4: D'Prime for Emotion Recognition - EMOTICOM Emotion Recognition Task.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  15. Biofluids: Serum Escitalopram levels

    Time frame: 3 Years

  16. PET Imaging: Cerebral (particularly hippocampal) presynaptic density, as measured with 11 C-UCB-J-PET.

    Time frame: 3 Years

    Collected in a sub-sample of participants.

Secondary outcomes

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

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

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

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  3. Learning Secondary Outcome 3: Pre Extra Dimension Set Errors - 3Dimensional Intra/Extra Dimensional Shift.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  4. Learning Secondary Outcome 4: Proportion of Stays - Sequential Model-Based/Model-Free.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

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

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

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

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

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

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

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

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  9. Executive Function Secondary Outcome 1: Total Errors Adjusted - 3Dimensional Intra/Extra Dimensional Shift.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  10. Executive Function Secondary Outcome 2: Strategy Score - CANTAB Spatial Working Memory.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  11. Social Cognition Secondary Outcome 1: Fairness Sensitivity---------- Ultimatum Game

    Time frame: 3 Years

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

  12. Emotion Recognition Secondary Outcome 1: Detection threshold increasing - EMOTICOM Intensity Morphing.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  13. Emotion Recognition Secondary Outcome 2: Affective bias in increasing condition - EMOTICOM Intensity Morphing.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  14. Emotion Recognition Secondary Outcome 3: Affective bias for Hit Rate - EMOTICOM Emotion Recognition Task.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  15. Emotion Recognition Secondary Outcome 4: Hit Rate for Emotion Recognition - EMOTICOM Emotion Recognition Task.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  16. Faces and geometric figure discrimination Outcome 1: Accuracy - Faces fMRI paradigm

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  17. Faces and geometric figure discrimination Outcome 2: Response Speed - Faces fMRI paradigm.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  18. Memory Outcome 1: Total Errors Adj - CANTAB Paired Associates Learning

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  19. Memory Outcome 2: First Trial Memory Score - CANTAB Paired Associates Learning.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  20. Memory Outcome 3: Between Search Errors - CANTAB Spatial Working Memory.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  21. Attention Outcome 1: Target Sensitivity (A') - CANTAB Rapid Visual Processing.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  22. Attention Outcome 2: Latency - CANTAB Rapid Visual Processing

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  23. Attention Outcome 3: Probability of False Alarms - CANTAB Rapid Visual Processing

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  24. Risky Decision Making Outcome Outcome 1. Quality of Decision Making - EMOTICOM Cambridge Gamble Task.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  25. Risky Decision Making Outcome 2: Risk Adjustment - EMOTICOM Cambridge Gamble Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  26. Risky Decision Making Outcome 3: Overall Proportion Bet - EMOTICOM Cambridge Gamble Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  27. Risky Decision Making Outcome 4: Deliberation Time - EMOTICOM Cambridge Gamble Task.

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  28. Psychomotor Speed Outcome 1: Simple reaction time - CANTAB Reaction Time Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  29. Psychomotor Speed Outcome 2: Five Choice reaction time - CANTAB Reaction Time Task

    Time frame: 3 Years

    Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.

  30. Neural Activations and Correlations - Reinforcement Learning fMRI paradigm

    Time frame: 3 Years

    Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.

  31. Neural Activations and Correlations - Faces fMRI paradigm

    Time frame: 3 Years

    Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.

  32. Resting State fMRI

    Time frame: 3 Years

    Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.

  33. Structural VBM

    Time frame: 3 Years

    Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.

  34. Diffusion Tensor Imaging

    Time frame: 3 Years

  35. Profile of Mood State Score

    Time frame: 3 Years

  36. Beck Depression Inventory-II Score

    Time frame: 3 Years

  37. State-Trait Anxiety Inventory Scale -State Score

    Time frame: 3 Years

  38. State and Trait Aggression Questionnaire-State Score

    Time frame: 3 Years

  39. Baret Impulsivity Scale-State Score

    Time frame: 3 Years

  40. Visual Analogue Scale Score

    Time frame: 3 Years

  41. Interpersonal Reactivity Index Score

    Time frame: 3 Years

  42. Obsessive- Compulsive Inventory Score

    Time frame: 3 Years

  43. Brief Symptom Checklist Score

    Time frame: 3 Years

  44. Pittsburgh Sleep Quality Index 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. State and Trait Aggression Questionnaire -Trait Score

    Time frame: 3 Years

  20. Barret Impulsivity 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 -Trait Score

    Time frame: 3 Years

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

    Time frame: 3 Years

  28. Mindful Attention and Awareness Scale -Trait Score

    Time frame: 3 Years

  29. Mindful Attention and Awareness Scale -State 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 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
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Nov 18, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.