Clinical trial

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

Name

H-18038352

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.

Trial arms

Trial start

2020-04-28

Estimated PCD

2022-10-30

Trial end

2022-10-30

Status

Completed

Phase

Early phase I

Treatment

Escitalopram 20 mg

20mg daily for approximately 3 weeks.

Arms:

Intervention Group

Placebo

Placebo daily for approximately 3 weeks.

Arms:

Control Group

Size

Primary endpoint

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

3 years

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

3 Years

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

3 Years

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

3 Years

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

3 Years

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

3 Years

Reinforcement Behaviour Model

3 Years

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

3 Years

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

3 Years

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

3 Years

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

3 Years

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

3 Years

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

3 Years

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

3 Years

Biofluids: Serum Escitalopram levels

3 Years

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

3 Years

Eligibility criteria

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.

Protocol

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Updated at

2023-11-18

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug