Psilocybin for Treatment of OCD-2
NCT06992999
Anxiety Disorders, Compulsive Personality Disorder
Tucson, Arizona, United States
View Trial DetailsNCT Number: NCT07822516
This study will establish a standardized, multi-dimensional prospective longitudinal cohort for obsessive-compulsive disorder. It seeks to explore differences in symptom trajectories, functional trajectories, treatment responses, and long-term outcomes among different OCD clinical subgroups. Additionally, it will examine whether multi-modal measures (including clinical features, neuropsychological tests, neuroimaging, electroencephalography (EEG), magnetoencephalography (MEG), functional near-infrared spectroscopy (fNIRS), and blood and stool biospecimens) can explain clinical heterogeneity and predict treatment response and long-term prognosis.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
【First-episode obsessive-compulsive disorder subgroup】
Exclusion criteria
Time frame: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up
This scale was developed by Goodman et al. It is a widely used self-assessment tool for obsessive-compulsive symptoms both domestically and internationally, consisting of 10 items and 42 sub-items. The scale employs a 5-point rating system ranging from 0 to 4. The total score ranges from 0 to 40. The higher the score, the more severe the obsessive-compulsive symptoms. A total score of 8-15 indicates mild obsessive-compulsive symptoms, 16-25 indicates moderate symptoms, and a score above 25 indicates severe symptoms. Its Chinese version was introduced and validated for reliability and validity by our research group, and has been extensively adopted in both clinical practice and research settings. In the present study, Y-BOCS scores will be applied for participant screening at enrollment, and will also serve as an assessment tool for symptom severity during follow-up visits.
Time frame: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up
This scale was revised by Beck et al. and is a self-assessment tool used to evaluate the degree of depression. It consists of 21 items and is used to assess the severity of depressive symptoms. This scale uses a four-point rating system from 0 to 3. The total score ranges from 0 to 13 indicating no depression, 14 to 19 indicating mild depression, 20 to 28 indicating moderate depression, and 29 to 63 indicating severe depression.
Time frame: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up
This scale was developed by Beck et al. It consists of 21 items, each of which is rated on a scale of 0 to 3, representing four levels. It is a self-assessment tool for evaluating anxiety symptoms. The total score is the sum of all items, with a score range of 0 to 63. The higher the score, the more severe the anxiety. A total score of 15-25 indicates mild anxiety, 26-35 indicates moderate anxiety, and above 36 indicates severe anxiety. The Chinese version of this scale has good reliability and validity and is widely used in the assessment of anxiety symptoms.
Time frame: From study baseline until the end of study follow-up (variable follow-up duration across participants)
Adverse events prospectively captured during follow-up are documented, includes adverse events that may occur during the actual phamachotherapy treatment process of the research participants, as well as during psychological treatment or other intervention studies. During the research, the occurrence time, manifestation form, severity, handling measures, and outcome of the adverse events will be recorded.Each participant is counted once if one or more adverse events newly occur after study enrolment, regardless of total event episodes. Data will be summarized using participant counts and corresponding proportions.
Time frame: From study baseline until the end of study follow-up (variable follow-up duration across participants)
Suicidal-related events include suicidal ideation, non-suicidal self-harm and suicide attempts, identified using the C-SSRS structured interview. A participant will be counted only once if one or more suicidal-related events newly occur after study enrolment during follow-up, regardless of total event episodes. Data will be summarized as participant counts and corresponding proportions.
Time frame: From study baseline until the end of study follow-up (variable follow-up duration across participants)
Serious adverse events are defined according to ICH-GCP criteria. Events are documented using verbatim clinical descriptions obtained from study follow-up interviews. A participant will be counted only once if any serious adverse event occurs during follow-up, irrespective of the total number of individual events experienced. Only serious adverse events newly occurring after study enrolment are counted. Data will be summarized as participant counts and corresponding proportions.
Contact information is provided by the study sponsor or research team.
Shanghai Mental Health Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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