The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder

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• Depressive Disorder, Major 2,741

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.

Lead sponsor

This is the only study on the registry with Sharmin Ghaznavi as lead sponsor.

Study arms

• Experimental
  Psilocybin

  25mg Psilocybin

  Drug: Psilocybin

Interventions

• DrugPsilocybin

  COMP360 (Brand name of psilocybin to be used)

Primary outcomes

1. Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ)

   A transdiagnostic state measure of rumination over the previous two weeks consisting of 9 items on a 5 point Likert scale from 0 (Never/Rarely) to 4 (All The Time).

   Time frame: Baseline, and 3 weeks, 6 weeks, 9 weeks, and 12 weeks after psilocybin administration.

2. Change in Resting-State Functional Connectivity

   Changes in resting-state activity during functional magnetic resonance imaging(fMRI) scans.

   Time frame: Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.

3. Change in Self-Attribution Task performance

   Participants are shown words one at a time and asked to answer if each of the words apply to 'Self' or 'Other'.

   Time frame: Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.

4. Change in Task-Based Activity during Self-Attribution Task

   Changes in activity in the default mode network during functional magnetic resonance imaging(fMRI) scans while participants perform a self-attribution task.

   Time frame: Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.

Secondary outcomes

1. Change in Montgomery-Asberg Depression Rating Scale(MADRS)

   The MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity.

   Time frame: Baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.

2. Change in Quick Inventory of Depressive Symptomatology Self Report - 16 item (QIDS-SR-16)

   The 16-item QIDS-SR-16 a self-rated scale designed to assess the severity of depressive symptoms in the nine diagnostic symptom domains of a major depressive episodes, exclusive of atypical or melancholic symptoms. The QIDS-SR-16 is sensitive to change with various treatments, demonstrating its utility in research settings. The total score ranges from 0 to 27 with 0 representing no depression and 27 representing severe depression.

   Time frame: Baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.

3. Change in Positive and Negative Affect Schedule (PANAS)

   The PANAS measures the acute emotional drug effects and comprises 2 mood scales that measure positive and negative affect. Participants respond to 20 items using a 5-point scale that ranges from "slightly or not at all (1)" to "extremely (5)". A total higher score on the positive affect questions indicates more of a positive affect while a lower score on the negative affect questions indicates less of a negative affect.

   Time frame: Baseline, the day of psilocybin administration and at 3 weeks and 12 weeks after psilocybin administration.

4. Change in Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)

   The SIGH-ADS is a 25 item scale of the severity of depressive symptoms in terms of Hamilton's 17 item depression scale (score range 0-52) and the addendum of eight atypical symptoms (score range from 0-26). Higher scores are associated with more severe depression symptoms.

   Time frame: Baseline and 3 weeks and 12 weeks after psilocybin administration.

5. Change in Ruminative Response Scale (RRS)

   A self-report measure of describing one's responses to depressed mood, consists of 22 items and three factors (Depression, Brooding, and Reflection). Each item is rated on a 4-point Likert scale ranging from 1 (never) to 4 (always). The total score ranges from 22 to 88, with higher scores indicating higher tendency to ruminate, i.e. higher trait rumination.

   Time frame: Baseline and 12 weeks after psilocybin administration.

6. Change in Rumination Reflection Questionnaire (RRQ)

   The RRQ measures the extent to which a person tends to ruminate or engage in self-reflection. It consists of 24 items measured on a 5 point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree),12 items which assess the tendency to ruminate, and 12 items which assess the tendency to engage in self reflection.

   Time frame: Baseline and 12 weeks after psilocybin administration.

7. Change in Penn State Worry Questionnaire (PSWQ)

   The PSWQ is a 16-item questionnaire that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). The PSWQ attempts to measure the excessiveness, generality, and uncontrollable dimensions of worry.

   Time frame: Baseline and 12 weeks after psilocybin administration.

8. Change in NEO-Five-Factor Inventory (NEO-FFI)

   The NEO-FFI is a 60-item psychological personality inventory that assesses based on the five- factor model: Openness to Experience, Conscientiousness, Extraversion, Agreeableness, and Neuroticism. Participants are asked to select the response that best represents their opinion on a 5-point scale: 0-Strongly Agree, 1-Agree, 2-Neutral, 3-Disagree, 4-Strongly Disagree.

   Time frame: Baseline and 12 weeks after psilocybin administration.

9. Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF)

   The BRIEF is a 75-item scale designed to assess executive function and self-regulation. Participants choose how often certain behaviors were problematic over the past month N-never, S-sometimes, O-often.

   Time frame: Baseline and 12 weeks after psilocybin administration.

10. Change in Cognitive Flexibility Inventory (CFI

    The CFI is a brief self-report measure of the type of cognitive flexibility necessary for individuals to successfully challenge and replace maladaptive thoughts with more balanced and adaptive thinking. The measure consists of 20 items and participants indicate the extent to which they agree or disagree with the statements in the items, on a scale from 1-Strongly Disagree to 7-Strongly Agree.

    Time frame: Baseline and 12 weeks after psilocybin administration.

11. Change in Emotional Faces Flanker Task

    This task examines executive functioning as it assesses the ability to ignore/inhibit irrelevant flanking information in order to respond to the central task.

    Time frame: Baseline, day of psilocybin administration, and 3 weeks and 12 weeks after psilocybin administration.

12. Change in Depression Implicit Attitudes Task (IAT)

    The IAT provides a measure of the strength of association between four categories by pairing two concept categories (e.g., Me/Not-Me) with two attribution categories (e.g., Happy/Sad).

    Time frame: Baseline, day of psilocybin administration, and 3 weeks and 12 weeks after psilocybin administration.