Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Montgomery-Åsberg Depression Rating Scale (MADRS) |
The MADRS is a validated 10-item questionnaire to assess depression severity and is commonly used to assess efficacy of an intervention in clinical trials. Each item of the MADRS is measured on a scale of 0 to 6 (for a total score of 0 to 60) with higher scores indicating more severe depression. The MADRS includes questions on the following symptoms: 1. Reported sadness; 2. Apparent sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; 10. Suicidal thoughts. Items are scored via a clinical interview that progresses from more broadly phrased questions about symptoms to more detailed queries that allow a precise rating of severity. |
Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3) |
|
| Secondary |
Warwick Edinburgh Mental Well-Being Scale (WEMWBS) |
The WEMWBS was designed to measure the psychological well-being of a population and has been shown to be responsive to novel interventions such as psychedelics. WEMWBS has 14 questions scored using a five-point Likert scale. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing. Items on the questionnaire are rated on a 5-point scale, where 1= "None of the time", 2= "rarely", 3= "some of the time", 4= "often", 5= "all the time". Scores reflect feelings and thoughts in the two weeks prior to answering the questionnaire. The WEMWBS assesses both emotional and functional aspects of mental well-being. Total scores range from 14 to 70, with higher scores correlating to higher levels of well-being. |
Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3) |
|
| Secondary |
Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety |
The PROMIS Anxiety measure focuses on fear (e.g., worry, feelings of panic), anxious misery (e.g., dread), hyperarousal (e.g., tension, nervousness, restlessness), and somatic symptoms related to arousal (e.g., cardiovascular symptoms, dizziness) and has been found to be a clinically validated measure of anxiety. The PROMIS 8A--Anxiety is comprised of eight items, each rated on a scale from 1 ("Never") to 5 ("Always"). Total scores range from 8 to 40, with higher scores correlating to higher levels of anxiety. |
Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3) |
|
| Secondary |
Sheehan Disability Scale (SDS) |
The SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the patient's life are impaired by psychiatric symptoms, including depression. This scale has been used widely in psychopharmacology randomized, controlled trials and has been accepted by the Food and Drug Administration (FDA) for functional disability labeling. The SDS uses visual-spatial, numeric, and verbal descriptive anchors simultaneously to assess disability across 3 domains: work, social life, and family life. The SDS asks participants to rate the extent to which their 1) work/school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analogue scale. Total scores range from 0 to 30, with higher scores correlating to higher levels of disability. |
Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3) |
|
| Secondary |
Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF) |
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form version contains 16 items assessing changes in quality of life, divided into the following sections: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. A total score is derived from summing the first 14 items on the scale, with the last 2 items serving as stand-alone queries. Total score ranges from 14 to 70, with higher scores correlating with higher levels of quality of life. |
Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3) |
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