Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
NCT ID: NCT03429075
Last Updated: 2024-10-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2019-01-07
2020-10-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Measurement of Serum Inflammatory Markers in Patients Treatment-resistant Depression Given Psilocybin
NCT07164755
Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression
NCT04670081
Psilocybin and Depression
NCT03380442
Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression
NCT07211438
Psilocybin for Major Depressive Disorder (MDD)
NCT06308653
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Psilocybin
Patients receive Psilocybin
Psilocybin + Placebo
Multiple dosing days psilocybin vs 6 weeks of daily placebo
Escitalopram
Patients receive Escitalopram
Psilocybin + Escitalopram
Multiple dosing days psilocybin vs 6 weeks of daily escitalopram
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Psilocybin + Placebo
Multiple dosing days psilocybin vs 6 weeks of daily placebo
Psilocybin + Escitalopram
Multiple dosing days psilocybin vs 6 weeks of daily escitalopram
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Depression of moderate to severe degree (17+ on the 17-item Hamilton Depression Scale (HAM-D)).
3. No Magnetic Resonance Imaging (MRI) contraindications
4. No SSRI contraindications
5. Has a general practitioner (GP) or other mental healthcare professional who can confirm diagnosis
6. 18-80 years of age
7. Males and females
8. Sufficiently competent with English language
Exclusion Criteria
2. Immediate family member with a diagnosed psychotic disorder
3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. creatine clearance:renal clearance (CLRC) \< 30 ml/min etc.)
4. History of serious suicide attempts requiring hospitalisation.
5. Significant history of mania (determined by study psychiatrist and medical records)
6. Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder
7. Blood or needle phobia
8. Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
9. Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
10. Current drug or alcohol dependence
11. No email access
12. Use of contraindicated medication
13. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alexander Mosely Charitable Trust
OTHER
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David J Nutt, Medicine
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Imperial College Hammersmith campus
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8.
Carhart-Harris R, Giribaldi B, Watts R, Baker-Jones M, Murphy-Beiner A, Murphy R, Martell J, Blemings A, Erritzoe D, Nutt DJ. Trial of Psilocybin versus Escitalopram for Depression. N Engl J Med. 2021 Apr 15;384(15):1402-1411. doi: 10.1056/NEJMoa2032994.
Erritzoe D, Barba T, Greenway KT, Murphy R, Martell J, Giribaldi B, Timmermann C, Murphy-Beiner A, Jones MB, Nutt D, Weiss B, Carhart-Harris R. Effect of psilocybin versus escitalopram on depression symptom severity in patients with moderate-to-severe major depressive disorder: observational 6-month follow-up of a phase 2, double-blind, randomised, controlled trial. EClinicalMedicine. 2024 Sep 21;76:102799. doi: 10.1016/j.eclinm.2024.102799. eCollection 2024 Oct.
Peill J, Marguilho M, Erritzoe D, Barba T, Greenway KT, Rosas F, Timmermann C, Carhart-Harris R. Psychedelics and the 'inner healer': Myth or mechanism? J Psychopharmacol. 2024 May;38(5):417-424. doi: 10.1177/02698811241239206. Epub 2024 Apr 12.
Szigeti B, Weiss B, Rosas FE, Erritzoe D, Nutt D, Carhart-Harris R. Assessing expectancy and suggestibility in a trial of escitalopram v. psilocybin for depression. Psychol Med. 2024 Jun;54(8):1717-1724. doi: 10.1017/S0033291723003653. Epub 2024 Jan 22.
Nayak SM, Bari BA, Yaden DB, Spriggs MJ, Rosas FE, Peill JM, Giribaldi B, Erritzoe D, Nutt DJ, Carhart-Harris R. A Bayesian Reanalysis of a Trial of Psilocybin versus Escitalopram for Depression. Psychedelic Med (New Rochelle). 2023 Mar;1(1):18-26. doi: 10.1089/psymed.2022.0002. Epub 2022 Oct 28.
Murphy R, Kettner H, Zeifman R, Giribaldi B, Kartner L, Martell J, Read T, Murphy-Beiner A, Baker-Jones M, Nutt D, Erritzoe D, Watts R, Carhart-Harris R. Therapeutic Alliance and Rapport Modulate Responses to Psilocybin Assisted Therapy for Depression. Front Pharmacol. 2022 Mar 31;12:788155. doi: 10.3389/fphar.2021.788155. eCollection 2021.
Daws RE, Timmermann C, Giribaldi B, Sexton JD, Wall MB, Erritzoe D, Roseman L, Nutt D, Carhart-Harris R. Increased global integration in the brain after psilocybin therapy for depression. Nat Med. 2022 Apr;28(4):844-851. doi: 10.1038/s41591-022-01744-z. Epub 2022 Apr 11.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-000219-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17HH3790
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.