Trial · NCT06480500
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Suicidality severity using the Columbia-Suicide Severity Rating Scale (C-SSRS) | 30 Days, up to 91 Days. | The CSSRS evaluates suicidal ideation and behaviour. The CSSRS evaluates suicidal ideation and behaviour. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care). |
| Secondary | Objective Depressive Symptom Severity using the Montgomery-Asberg Depression Rating Scale (MADRS) | Day 30, Day 91 | The MADRS is a scale measuring objective 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. |
| Secondary | Subjective Depressive Symptom Severity using the McIntyre and Rosenblat Rapid Response Scale (MARRRS) | Day 30, Day 91 | The MARRRS is a self-reported 14-item self-report measure of depressive symptoms present during the past 72 hours. Total score ranges from 0 to 42; a higher score indicates greater symptom severity. |
| Secondary | Subjective Depressive Symptom Severity using Quick Inventory for Depressive Symptomatology, Self-Report, 16-item (QIDS-SR-16) | Day 30, Day 91 | The QIDS-SR-16 total score ranges from 0 to 27 with 0 representing no depression and 27 representing severe depression. |
| Secondary | Symptom Severity and Treatment response using the Clinical Global Impressions Scale (CGI) | Day 30, Day 91 | The CGI severity module assesses the severity of a person's depressive illness using a seven-point Likert scale, ranging from "Normal, not at all depressed" to "Among the most extremely depressed patients". The CGI improvement module evaluates the global improvement of a person's condition since their last visit on a seven-point Likert scale, ranging from "Very much improved" to "Very much worse". |
| Secondary | Dissociative Symptom Severity using the Clinician-Administered Dissociative States Scale (CADSS), 23-item | 30 minutes Post-Infusion | The CADSS measures objective dissociative symptom severity post infusion. Total scores on the 23-item CADSS range from 0 to 92; a higher score denotes greater dissociative symptom severity. |
| Secondary | Treatment-Emergent Psychiatric Symptoms using the Brief Psychiatric Rating Scale (BPRS) | 30 minutes Post infusion, Day 30, Day 91 | The BPRS rating scale has 18 items, each item rated on a severity scale of 1 (not present) to 7 (extremely severe). 0 is entered if the item is not assessed. |
| Secondary | Treatment-Emergent Manic Symptoms using the Young Mania Rating Scale (YMRS) | 30 minutes Post infusion, Day 30, Day 91 | The Young Mania Rating Scale (YMRS) is a clinical interview scale to assess the severity of manic states and in this study to look at treatment-emergent mania. Total scores range from 0 to 60, with higher scores indicative of greater symptom severity. |
| Secondary | Mystical Type Experiences using the Mystical Experiences Questionnaire (MEQ) | 30 minutes Post Infusion, Day 30, Day 91 | The MEQ consists of 30 items, each item rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The MEQ total score is computed by taking the average response to all items. |
| Secondary | Subjective Wellbeing using the World Health Organization-5 Well-Being Index (WHO-5) | Day 30, Day 91 | The WHO-5 is a measure of overall well-being, rated on a scale of 0 to 25, with higher scores denoting higher quality of life. |
| Secondary | Impairments in Work and Activities using the World Productivity and Impairment Questionnaire (WPAI) | Day 30, Day 91 | The WPAI is a six-item self-administered rating scale measuring work absenteeism, presenteeism, and productivity loss and daily activity impairment. Individuals are asked to rate to what extent health problems affected their ability to do regular daily activities other than work at a job (0-No effect on daily activities to 10-Completely prevented me from doing my daily activities). Respondents who are currently employed are additionally asked to rate the number of hours missed from work due to health problems, the number of hours missed due to other reasons (e.g., vacation, time off to participate in this study), and the number of hours worked in the past seven days, as well as to what extent health problems affected productivity while working (0-No effect on my work to 10-Completely prevented me from working). Responses to each question are scaled to an overall percentage score (0 to 100), with higher values denoting greater impairment |
| Secondary | Subjective Cognitive Impairment using the Perceived Deficits Questionnaire - Depression - 5-Item (PDQ-5-D) | Day 30, Day 91 | The PDQ-5-D total scores range from 0 to 20, with greater scores indicative of greater subjective cognitive impairment. |
| Secondary | Cognitive Function using the Digit Symbol Substitution Test (DSST) | Day 30, Day 91 | The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within 90 seconds for a total possible score of 0 to 90. A higher score reflects greater performance. |
| Secondary | Cognitive Processing Speed using the Trail Making Test A (TMT-A) | Day 30, Day 91 | The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants are asked to connect circles in numerical sequence. If a participant makes a mistake, the administrator points out the error, and the participant must return to the last correct circle and continue the task. Lower scores represent better performance. |
| Secondary | Executing Functioning using the Trail Making Test B (TMT-B) | Day 30, Day 91 | The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants are asked to connect circles in alternating numerical and alphabetical sequence (e.g., 1-A-2-B). If a participant makes a mistake, the administrator points out the error, and the participant must return to the last correct circle and continue the task. Lower scores represent better performance. |
| Secondary | Anxiety using the Generalized Anxiety Disorder-7 (GAD-7) | Day 30, Day 91 | Total score ranges from 0 to 21; a higher score denotes greater symptom severity. |
| Secondary | Hedonic/Pleasure Capacity using the Snaith-Hamilton Pleasure Scale (SHAPS) | Day 30, Day 91 | The SHAPS total score ranges from 14 to 56, wherein a higher score indicates greater hedonic capacity (lower anhedonic severity). |
| Secondary | Reaction Time using the Choice Reaction Time Identification Task (CRT) | Day 30, Day 91 | For the CRT, 4 boxes are presented on the screen in a horizontal array. Each box has an assigned response key (by default, the response keys are matched spatially to the position of their assigned boxes: DFJK). After a fixed amount of time, one of the boxes turns red and participants are asked to press the corresponding response key as fast as possible. The response time for correct responses is recorded, with larger numbers representing slower reaction time. |
| Secondary | Psychomotor signs of depression using the Core Assessment of Psychomotor Change (CORE) | Day 30, Day 91 | The CORE is an observer-rated instrument evaluating cognitive processing disorders (non-interactiveness), agitation, and motor retardation. Scores range from 0 to 54, with higher scores representing more psychomotor signs of depression. |
| Secondary | Verbal Fluency using the FAS test | Day 30, Day 91 | The F-A-S Test assesses phonemic verbal fluency by requesting an individual to orally produce words that begin with the letters F, A and S. High scores indicate better phonemic verbal fluency. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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