A Phase 2 interventional study of Psilocybin + Placebo and Psilocybin + Escitalopram in Depressive Disorder, Major, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Imperial College London · Phase 2, Interventional, and Treatment
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Among 96 studies in Depressive Disorder, Major with a site in United Kingdom — 17 open to participants now, 19 under way, 7 of them phase 3. Depressive Disorder, Major · United Kingdom.
Among the 96 studies in Depressive Disorder, Major with a site in United Kingdom, this one is the 63rd largest by enrollment of the 84 interventional ones that give a count, is one of 10 that started in 2019, is one of 17 in phase 2, and was the 31st registered.
3,047 studies on the registry are indexed under Depressive Disorder, Major; 593 are open to participants now.
Browse Depressive Disorder, Major studies →17 of the 96 studies in Depressive Disorder, Major with a site in United Kingdom are open now. Recruiting first, the newest first:
University of Oxford · Sites in United Kingdom
Ages 18–65
Eli Lilly and Company · Sites in United Kingdom, United States, Australia and 12 more countries
Ages 18–75
Eli Lilly and Company · Sites in United Kingdom, United States, Australia and 12 more countries
Ages 18–75
Draig Therapeutics Ltd · Sites in United Kingdom, United States, Bulgaria and 2 more countries
Ages 18–75
Cybin IRL Limited · Sites in United Kingdom, United States, Australia and 5 more countries
Ages 18–85
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 413 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 294 (71%) stop at 75 or younger; 55 take children under 18; 99 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
96 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 21 · Phase 3 23 · Phase 4 4
First in 2004; this study’s year is marked. 10 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 59 is below the median of 79 across 2,533 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 141 across the 84 interventional studies, 46 across the 12 observational. Of the 67 that completed or were terminated, 29 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
59 of 96 have an industry lead sponsor. The 10 most frequent:
Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Imperial College London has 1 study filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
8 of the studies in Depressive Disorder, Major with a site in United Kingdom that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06793397Phase 3Cybin IRL LimitedA Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder | 2027-06-07 |
| NCT06963021Phase 3Neurocrine BiosciencesNBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | 2027-07 |
| NCT06470035Neurovalens Ltd.Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD) | 2027-04 |
| NCT07228468King's College LondonHome-Based Transcranial Direct Current Stimulation In Major Depressive Disorder (HOME) | 2027-05-15 |
| NCT07879924Mersey Care NHS TrustDual Neuromodulation for Depression: Boosting TMS With tES | 2027-08 |
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Among the 96 studies in Depressive Disorder, Major with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Inclusion Criteria:
Key exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive Psilocybin
Drug: Psilocybin + Placebo
Patients receive Escitalopram
Drug: Psilocybin + Escitalopram
Multiple dosing days psilocybin vs 6 weeks of daily placebo
Drug pages: Psilocybin · Escitalopram
Multiple dosing days psilocybin vs 6 weeks of daily escitalopram
Percentage Change of the BOLD Signal
Patients were tested with functional magnetic resonance imaging (fMRI) to measure brain brain responses to emotional faces before and after the treatment. The 2 values of BOLD signal (before and after exposure to emotional faces) were used to estimate a percentage value per patient and then these were used to estimated a group percentage change.
Time frame: Baseline measure vs 6 weeks post 1st psilocybin dosing
Change in QIDS-16: Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-16)
Change in QIDS-16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 Diagnostic Statistical Manual (DSM-IV) symptom criteria for depression. Each response is graded 0-4 (none-severe symptoms). Questions 1-4 concern sleep disturbances, Question 5 addresses sad mood, Questions 6-9 appetite/weight, Question 10 concentration, Question 11 self-criticism, Question 12 suicidal ideation, Question 13 interest, Q14 energy/fatigue and Questions 15-16 psychomotor agitation/retardation. All questions that address the same topic are grouped and only the highest score from each group is summed up together with the other questions in order to produce a total score. Scores can range from 0-27 and depression severity is graded based on the total score in the following way: 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression Lower score =better outcome (less depression)
Time frame: Baseline vs 6 weeks post 1st psilocybin dosing
Change in Hamilton Depression Scale (HAMD-17)
HAMD-17: clinician rated Hamilton Depression Scale of depression severity. Range of scores: 0-52: where 0-7 is normal, 8-16 is mild, 17-23 is moderate, \>23 is severe. A threshold score of 17 is the entry: a score of 17 or higher indicated moderate-severe depression and was a requirement for entry into this trial at the screening point. This baseline does not refer to the screening point, it refers to the HAMD conducted 7-10 days before psilocybin dosing. A higher decrease in the HAMD (larger negative change score) is a better outcome.
Time frame: Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose
Change in Beck Depression Inventory (BDI-IA)
BDI-IA: patient-rated Beck Depression Inventory, depressive symptomatology scale. Higher score = worse depression. The total score range is 0-63: where 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe Higher negative score = greater decrease in depression scores 6 weeks after each treatment arm = better outcome.
Time frame: Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose
Change in MADRS
MADRS - Montgomery-Asberg Depression Rating Scale, clinician-rated measure of depression. This scale is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.36 The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression," and a total score of 60 or greater indicates "very severe depression." A higher decrease in the MADRS (larger negative change score) is a better outcome.
Time frame: Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose
Number of Patients Who "Responded": Quick Inventory of Depressive Symptomatology (QIDS-16) Response at 6 Weeks
Number of patients who "responded" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). "Response" is defined by a decrease in QIDS score of 50% from baseline. Higher number of patients who responded = better outcome for treatment arm.
Time frame: Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose
Number of Patients Who "Remitted": QIDS-16 Remission Rate
Number of patients who "remitted" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). "Remission" is defined by having a QIDS score below 5 at the 6 week point = no depression. Higher remission rate = better outcome (less depressed patients after treatment)
Time frame: Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose
| Milestone | Psilocybin | Escitalopram |
|---|---|---|
| Started | 30 | 29 |
| Completed | 30 | 29 |
| Not completed | 0 | 0 |
Patients were tested with functional magnetic resonance imaging (fMRI) to measure brain brain responses to emotional faces before and after the treatment. The 2 values of BOLD signal (before and after exposure to emotional faces) were used to estimate a percentage value per patient and then these were used to estimated a group percentage change.
| percentage change in BOLD signal | Psilocybin | Escitalopram |
|---|---|---|
| Percentage Change of the BOLD Signal | -0.08 ± 0.45 | 0.43 ± 0.62 |
Change in QIDS-16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 Diagnostic Statistical Manual (DSM-IV) symptom criteria for depression. Each response is graded 0-4 (none-severe symptoms). Questions 1-4 concern sleep disturbances, Question 5 addresses sad mood, Questions 6-9 appetite/weight, Question 10 concentration, Question 11 self-criticism, Question 12 suicidal ideation, Question 13 interest, Q14 energy/fatigue and Questions 15-16 psychomotor agitation/retardation. All questions that address the same topic are grouped and only the highest score from each group is summed up together with the other questions in order to produce a total score. Scores can range from 0-27 and depression severity is graded based on the total score in the following way: 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression Lower score =better outcome (less depression)
| score on a scale | Psilocybin | Escitalopram |
|---|---|---|
| Change in QIDS-16: Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-16) | -8 ± 1 | -6 ± 1 |
HAMD-17: clinician rated Hamilton Depression Scale of depression severity. Range of scores: 0-52: where 0-7 is normal, 8-16 is mild, 17-23 is moderate, \>23 is severe. A threshold score of 17 is the entry: a score of 17 or higher indicated moderate-severe depression and was a requirement for entry into this trial at the screening point. This baseline does not refer to the screening point, it refers to the HAMD conducted 7-10 days before psilocybin dosing. A higher decrease in the HAMD (larger negative change score) is a better outcome.
| units on a scale | Psilocybin | Escitalopram |
|---|---|---|
| Change in Hamilton Depression Scale (HAMD-17) | -10.5 ± 1 | -5.1 ± 1 |
BDI-IA: patient-rated Beck Depression Inventory, depressive symptomatology scale. Higher score = worse depression. The total score range is 0-63: where 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe Higher negative score = greater decrease in depression scores 6 weeks after each treatment arm = better outcome.
| units on a scale | Psilocybin | Escitalopram |
|---|---|---|
| Change in Beck Depression Inventory (BDI-IA) | -18.4 (-22.6 to -13.8) | -10.8 (-14.3 to -7.3) |
MADRS - Montgomery-Asberg Depression Rating Scale, clinician-rated measure of depression. This scale is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.36 The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression," and a total score of 60 or greater indicates "very severe depression." A higher decrease in the MADRS (larger negative change score) is a better outcome.
| score on a scale | Psilocybin | Escitalopram |
|---|---|---|
| Change in MADRS | 14.4 ± 1.7 | -7.2 ± 1.7 |
Number of patients who "responded" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). "Response" is defined by a decrease in QIDS score of 50% from baseline. Higher number of patients who responded = better outcome for treatment arm.
| participants | Psilocybin | Escitalopram |
|---|---|---|
| Number of Patients Who "Responded": Quick Inventory of Depressive Symptomatology (QIDS-16) Response at 6 Weeks | 21 | 14 |
Number of patients who "remitted" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). "Remission" is defined by having a QIDS score below 5 at the 6 week point = no depression. Higher remission rate = better outcome (less depressed patients after treatment)
| participants | Psilocybin | Escitalopram |
|---|---|---|
| Number of Patients Who "Remitted": QIDS-16 Remission Rate | 17 | 8 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psilocybin | 0/30 (0%) | 0/30 (0%) | 26/30 (86.7%) |
| Escitalopram | 0/29 (0%) | 0/29 (0%) | 24/29 (82.8%) |
| Event | Psilocybin | Escitalopram |
|---|---|---|
| HeadacheNervous system disorders | 20/30 | 15/29 |
| NauseaGastrointestinal disorders | 8/30 | 9/29 |
| FatigueGeneral disorders | 2/30 | 7/29 |
| AnxietyPsychiatric disorders | 0/30 | 4/29 |
| Dry mouthGastrointestinal disorders | 0/30 | 4/29 |
| PalpitationsCardiac disorders | 1/30 | 3/29 |
| Sleep disorderPsychiatric disorders | 1/30 | 3/29 |
| Feeling abnormalGeneral disorders | 0/30 | 3/29 |
| MigraineNervous system disorders | 3/30 | 1/29 |
| DiarrhoeaGastrointestinal disorders | 1/30 | 2/29 |
| Age, Categorical(Participants) | Psilocybin | Escitalopram | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 29 | 59 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Psilocybin | Escitalopram | Total |
|---|---|---|---|
| Mean | 43.3 ± 11.7 | 39.1 ± 9.7 | 41.2 ± 10.9 |
| Sex: Female, Male(Participants) | Psilocybin | Escitalopram | Total |
|---|---|---|---|
| Female | 11 | 9 | 20 |
| Male | 19 | 20 | 39 |
| Race/Ethnicity, Customized(participants) | Psilocybin | Escitalopram | Total |
|---|---|---|---|
| White | 28 | 24 | 52 |
| Asian | 1 | 4 | 5 |
| Mixed Asian + White | 1 | 1 | 2 |
| Region of Enrollment(participants) | Psilocybin | Escitalopram | Total |
|---|---|---|---|
| United Kingdom | 30 | 29 | 59 |
| No previous psilocybin use(participants) | Psilocybin | Escitalopram | Total |
|---|---|---|---|
| Number | 22 | 21 | 43 |
Plan to share: No
Ran from Jan 2019 to primary completion in Apr 2020, 15 months.
Results were first posted in Oct 2024, 4 years 6 months after primary completion.
Of 99 non-industry phase 2 interventional studies under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 57. This study's 15 months is below that.
Counting every sponsor, half of 195 studies reached it within 22 months; a quarter within 14 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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