- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Copenhagen, Denmark, DK-2100
- Neurobiology Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Group
The 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 pill.
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Placebo daily for approximately 3 weeks.
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Experimental: Intervention Group
The intervention group will be administered 20mg of Escitalopram daily for approximately 3 weeks.
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20mg daily for approximately 3 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Learning Primary Outcome 1: Mean errors Stage 1 (Learning) - Probability Reversal Learning.
Time Frame: 3 years
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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 years
|
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 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
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3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
Social Cognition Primary Outcome 2: Agent Guilt Score - Moral Emotions Task.
Time Frame: 3 Years
|
3. 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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
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3 Years
|
Biofluids: Serum Escitalopram levels
Time Frame: 3 Years
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3 Years
|
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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.
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3 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 Years
|
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 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
Resting State fMRI
Time Frame: 3 Years
|
Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.
|
3 Years
|
Structural VBM
Time Frame: 3 Years
|
Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.
|
3 Years
|
Diffusion Tensor Imaging
Time Frame: 3 Years
|
3 Years
|
|
Profile of Mood State Score
Time Frame: 3 Years
|
3 Years
|
|
Beck Depression Inventory-II Score
Time Frame: 3 Years
|
3 Years
|
|
State-Trait Anxiety Inventory Scale -State Score
Time Frame: 3 Years
|
3 Years
|
|
State and Trait Aggression Questionnaire-State Score
Time Frame: 3 Years
|
3 Years
|
|
Baret Impulsivity Scale-State Score
Time Frame: 3 Years
|
3 Years
|
|
Visual Analogue Scale Score
Time Frame: 3 Years
|
3 Years
|
|
Interpersonal Reactivity Index Score
Time Frame: 3 Years
|
3 Years
|
|
Obsessive- Compulsive Inventory Score
Time Frame: 3 Years
|
3 Years
|
|
Brief Symptom Checklist Score
Time Frame: 3 Years
|
3 Years
|
|
Pittsburgh Sleep Quality Index Score
Time Frame: 3 Years
|
3 Years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 Years
|
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 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
Activity Level Score
Time Frame: 3 Years
|
3 Years
|
|
Behavioural Inhibition/ Behavioural Avoidance Scale Score
Time Frame: 3 Years
|
3 Years
|
|
The Compulsive Personality Assessment Scale Score
Time Frame: 3 Years
|
3 Years
|
|
Sexuality Questionnaire Score
Time Frame: 3 Years
|
3 Years
|
|
Edinburgh Handedness Inventory Score
Time Frame: 3 Years
|
3 Years
|
|
Revised NEO Personality Questionnaire Score
Time Frame: 3 Years
|
3 Years
|
|
Family History Assessment Module Score
Time Frame: 3 Years
|
3 Years
|
|
Positive Life Events Score
Time Frame: 3 Years
|
3 Years
|
|
Stressful Life Events Score
Time Frame: 3 Years
|
3 Years
|
|
State and Trait Aggression Questionnaire -Trait Score
Time Frame: 3 Years
|
3 Years
|
|
Barret Impulsivity Scale-Trait Score
Time Frame: 3 Years
|
3 Years
|
|
The Penn State Worry Questionnaire- Trait Score
Time Frame: 3 Years
|
3 Years
|
|
The Penn State Worry Questionnaire- State Score
Time Frame: 3 Years
|
3 Years
|
|
The Self-Control Scale- Trait Score
Time Frame: 3 Years
|
3 Years
|
|
The Self-Control Scale- State Score
Time Frame: 3 Years
|
3 Years
|
|
State- Trait Anxiety Inventory- Trait Score
Time Frame: 3 Years
|
3 Years
|
|
The Warwick-Edinburgh Mental Well-being Scale -Trait Score
Time Frame: 3 Years
|
3 Years
|
|
The Warwick-Edinburgh Mental Well-being Scale -State Score
Time Frame: 3 Years
|
3 Years
|
|
Mindful Attention and Awareness Scale -Trait Score
Time Frame: 3 Years
|
3 Years
|
|
Mindful Attention and Awareness Scale -State Score
Time Frame: 3 Years
|
3 Years
|
|
The Intolerance of Uncertainty Scale - Trait Score
Time Frame: 3 Years
|
3 Years
|
|
The Intolerance of Uncertainty Scale - State Score
Time Frame: 3 Years
|
3 Years
|
|
Verran Snyder-Halpern (VSH) Sleep Scale Score
Time Frame: 3 Years
|
3 Years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Homberg JR. Serotonin and decision making processes. Neurosci Biobehav Rev. 2012 Jan;36(1):218-36. doi: 10.1016/j.neubiorev.2011.06.001. Epub 2011 Jun 12.
- Meneses A. Are 5-HT(1B/1D) and 5-HT(2A/2B/2C) receptors involved in learning and memory processes? IDrugs. 1999 Aug;2(8):796-801.
- Worbe Y, Savulich G, Voon V, Fernandez-Egea E, Robbins TW. Serotonin depletion induces 'waiting impulsivity' on the human four-choice serial reaction time task: cross-species translational significance. Neuropsychopharmacology. 2014 May;39(6):1519-26. doi: 10.1038/npp.2013.351. Epub 2014 Jan 2.
- Worbe Y, Savulich G, de Wit S, Fernandez-Egea E, Robbins TW. Tryptophan Depletion Promotes Habitual over Goal-Directed Control of Appetitive Responding in Humans. Int J Neuropsychopharmacol. 2015 Feb 5;18(10):pyv013. doi: 10.1093/ijnp/pyv013.
- Worbe Y, Palminteri S, Savulich G, Daw ND, Fernandez-Egea E, Robbins TW, Voon V. Valence-dependent influence of serotonin depletion on model-based choice strategy. Mol Psychiatry. 2016 May;21(5):624-9. doi: 10.1038/mp.2015.46. Epub 2015 Apr 14.
- Park SB, Coull JT, McShane RH, Young AH, Sahakian BJ, Robbins TW, Cowen PJ. Tryptophan depletion in normal volunteers produces selective impairments in learning and memory. Neuropharmacology. 1994 Mar-Apr;33(3-4):575-88. doi: 10.1016/0028-3908(94)90089-2.
- Sahakian BJ, Morris RG, Evenden JL, Heald A, Levy R, Philpot M, Robbins TW. A comparative study of visuospatial memory and learning in Alzheimer-type dementia and Parkinson's disease. Brain. 1988 Jun;111 ( Pt 3):695-718. doi: 10.1093/brain/111.3.695.
- Bland AR, Roiser JP, Mehta MA, Schei T, Boland H, Campbell-Meiklejohn DK, Emsley RA, Munafo MR, Penton-Voak IS, Seara-Cardoso A, Viding E, Voon V, Sahakian BJ, Robbins TW, Elliott R. EMOTICOM: A Neuropsychological Test Battery to Evaluate Emotion, Motivation, Impulsivity, and Social Cognition. Front Behav Neurosci. 2016 Feb 24;10:25. doi: 10.3389/fnbeh.2016.00025. eCollection 2016.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-18038352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of ManitobaNot yet recruitingHealthy | Healthy Diet
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King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States