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Effect of psilocybin on the positive valence system in treatment-resistant depression: a pilot clinical neuroimaging study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501092-11-00
Acronym
NIMAO/2021-2/JLC-01
Enrollment
20
Registered
2024-09-26
Start date
2024-11-05
Completion date
2025-09-26
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression, mental disorders

Brief summary

Brain activity measured by fMRI in regions involved in effort assessment before and after treatment: basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum, ventral tegmental area

Detailed description

Delta depression scores before & after treatment (Quick Inventory of Depressive Symptomatology, Clinician Rated and Self-report) at inclusion visit, 4 days, 1 month and 3 months., Delta of Behavioral Activation for Depression Scale (BADS) and Snaith-Hamilton Pleasure Scale (SHAPS) scores before and after treatment., Evaluation of therapy administration sessions by patients: satisfaction, number and severity of adverse events or tolerance problems reported., 5-Dimensional Altered States of Consciousness Questionnaire score.

Interventions

Sponsors

Centre Hospitalier Universitaire De Nimes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Brain activity measured by fMRI in regions involved in effort assessment before and after treatment: basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum, ventral tegmental area

Secondary

MeasureTime frame
Delta depression scores before & after treatment (Quick Inventory of Depressive Symptomatology, Clinician Rated and Self-report) at inclusion visit, 4 days, 1 month and 3 months., Delta of Behavioral Activation for Depression Scale (BADS) and Snaith-Hamilton Pleasure Scale (SHAPS) scores before and after treatment., Evaluation of therapy administration sessions by patients: satisfaction, number and severity of adverse events or tolerance problems reported., 5-Dimensional Altered States of Consciousness Questionnaire score.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026