Clinical Trial Radar

Aesthetic task

This task is designed to evoke and probe the nature and extent of the aesthetic experience. Two sets of stimuli will be presented. Each set consists of 20 pieces of self-selected music with 10 pieces inducing highly hedonic experiences and 10 neutral pieces. After stimulus presentation, subjects will rate how aesthetically moving the experience was, whether they experienced chills, and what the valence of the experience was on a Likert scale.

From enrolment until the second assessment session (up to 9 weeks after enrolment)

Monetary Incentive Delay (MID) Task

The MID task is established to evoke and assess reward and punishment, which are centrally involved in anhedonia. The task observes several stages of reward processing, i.e., reward prediction, anticipation and reward consumption. The aim of the paradigm is to maximize gain and avoid loss by fast reaction upon presentation of a target stimulus. A trial starts with the presentation of a cue, indicating the potential gain or loss (e.g., -1€, +3€). After a variable delay of for instance 3-5 seconds the target stimulus is shown, and subjects press a button as fast as possible. If the reaction is within a given time limit the amount is gained or loss avoided. Otherwise, the amount is not gained or lost. Each button press is followed by immediate feedback, showing the outcome and the accumulated amount of money.

From enrolment until the last imaging session (up to 8 weeks after enrolment)

Sexual arousal task

This task has been implemented by our group to assess changes to sexual arousal, a central and burdensome, yet often understudied, component of anhedonia. During this task, subjects are presented images intended to be sexually arousing and are instructed to denote the extent to which they find the image arousing.

From enrolment until the last imaging session (up to 8 weeks after enrolment)

Cognitive Flexibility Inventory (CFI)

The CFI is a 20-item self-report measure to assess two aspects of cognitive flexibility: the adaptive ability to perceive multiple alternative explanations for life occurrences and the ability to generate multiple alternative solutions to difficult situations, as well as having an internal locus of control, or the tendency to perceive difficult situations as somewhat controllable.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Intensity rating

A self-reported rating of the subjective intensity of the acute psychedelic experience will be collected after each medication session on a scale from 0 (not at all) to 4 (extreme).

From enrolment until the second medication session (up to 8 weeks after enrolment)

Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

The WEMWBS is a self-report scale which will be used to assess mental well-being over the course of study participation.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Beck-Depression-Inventory (BDI)

The BDI is a self-rated scale which is used to assess symptoms of depression.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Montgomery-Åsberg Depression Rating Scale (MADRS)

The MADRS is a observer-rated scale which is used to assess symptoms of depression.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Dimensional Anhedonia Rating Scale (DARS)

The DARS is a self-report scale that measures anhedonia across four domains on a five-point-likert scale.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Aesthetic Experiences Scale (AES)

The AES is a self-report scale which is used to assess aesthetic experiences in the form of 'aesthetic chills', the response of goose bumps and shivers in response to the arts.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Temporal Experience of Pleasure Scale (TEPS)

The TEPS is a self-rating scale which is used to assess the experience of anticipatory and consummatory experiences of pleasure.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Barcelona Music Reward Questionnaire (BMRQ)

The BMRQ is a psychometric scale designed to assess different factors underlying the experience of music reward, as measured through 20 items on a 5-point Likert scale.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

5-Dimensional Altered States of Consciousness Rating (5D-ASC)

Properties of the psychedelic experience as assessed via the 5D-ASC, a a 94-item self-report scale that assesses the participants' alterations from normal waking Consciousness.

From enrolment until the second medication session (up to 8 weeks after enrolment)

Mystical Experience Questionnaire (MEQ30)

Properties of the psychedelic experience as assessed via the MEQ30, a 30 point self-rated scale, which is used to measure the intensity of common aspects of a psychedelic experience (divided into mystical, positive mood, transendence of time and space, and ineffability).

From enrolment until the second medication session (up to 8 weeks after enrolment)

Challenging Experience Questionnaire (CEQ)

Properties of the psychedelic experience as assessed via the Challenging Experience Questionnaire (CEQ), an instrument designed to measure challenging psychological experiences associated with the acute effects of psychedelics.

From enrolment until the second medication session (up to 8 weeks after enrolment)

Connor-Davidson Resilience Scale (CD-RISC)

The CD-RISC is a self-rating scale which is used to assess changes in study participants' resilience over the course of their participation.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Cytokine panel

Changes in proinflammaotry cytokines, suchz as interleukin 6 and tumor necrosis factor alpha, which have been associated with depression and anhedonia, assessed via Legendplex cytokine panel

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Brain-derived neurotrophic factor (BDNF) concentration

Changes in blood markers which have been associated with depression and anhedonia, assessed via BDNF concentration.

From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)

Neural activity

Neural activity during MID and sexual arousal task, assessed via fMRI measurement.

Over the course of the three MRI sessions (3-14 days after enrolment, 1 day after the first medication session, 6 weeks after the second measurement)

Brain network dynamic complexity

Brain complexity measures during the hedonic experience assessed with fMRI, as assesed via integrated information decomposition and BOLD variability

Over the course of the three MRI sessions (3-14 days after enrolment, 1 day after the first medication session, 6 weeks after the second measurement)