Phase 2
Completed N=59
Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT03429075 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Percentage Change of the BOLD Signal — -0.08; 0.43 percentage change in BOLD signal
Summary
This is a randomised double-blind clinical trial. The aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective serotonin reuptake inhibitor (SSRI) escitalopram for major depressive disorder (MDD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change of the BOLD Signal |
-0.08; 0.43 | — |
| PRIMARY Change in QIDS-16: Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-16) |
-8; -6 | 0.17 |
| SECONDARY Change in Hamilton Depression Scale (HAMD-17) |
-10.5; -5.1 | — |
| SECONDARY Change in Beck Depression Inventory (BDI-IA) |
-18.4; -10.8 | — |
| SECONDARY Change in MADRS |
14.4; -7.2 | — |
| SECONDARY Number of Patients Who "Responded": Quick Inventory of Depressive Symptomatology (QIDS-16) Response at 6 Weeks |
21; 14 | — |
| SECONDARY Number of Patients Who "Remitted": QIDS-16 Remission Rate |
17; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Major depressive disorder (DSM-IV)
- Depression of moderate to severe degree (17+ on the 17-item Hamilton Depression Scale (HAM-D)).
- No Magnetic Resonance Imaging (MRI) contraindications
- No SSRI contraindications
- Has a general practitioner (GP) or other mental healthcare professional who can confirm diagnosis
- 18-80 years of age
- Males and females
- Sufficiently competent with English language
Key exclusion criteria
- Current or previously diagnosed psychotic disorder
- Immediate family member with a diagnosed psychotic disorder
- 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.)
- History of serious suicide attempts requiring hospitalisation.
- Significant history of mania (determined by study psychiatrist and medical records)
- Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder
- Blood or needle phobia
- Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
- Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
- Current drug or alcohol dependence
- No email access
- Use of contraindicated medication
- 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)
Data sourced from ClinicalTrials.gov (NCT03429075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.