Trial record 11 of 20 for:
psilocybin | Recruiting, Not yet recruiting Studies
Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms (Psilodep-RCT)
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| ClinicalTrials.gov Identifier: NCT03429075 |
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Recruitment Status :
Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
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Sponsor:
Imperial College London
Collaborator:
Alexander Mosely Charitable Trust
Information provided by (Responsible Party):
Imperial College London
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Brief 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 SSRI (selective serotonin reuptake inhibitor) escitalopram for major depressive disorder (MDD).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depressive Disorder, Major | Drug: Psilocybin + Placebo Drug: Psilocybin + Escitalopram | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms |
| Estimated Study Start Date : | March 2018 |
| Estimated Primary Completion Date : | March 2018 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
| Experimental: Psilocybin |
Drug: Psilocybin + Placebo
Single dose of psilocybin vs 6 weeks of daily placebo |
| Active Comparator: Escitalopram |
Drug: Psilocybin + Escitalopram
Single dose of psilocybin vs 6 weeks of daily escitalopram |
Primary Outcome Measures :
- functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline measure vs 1 week post-psilocybin dosing ]Change in blood oxygen level dependent (BOLD) signal during fMRI in response to emotional faces during an emotional faces paradigm done inside the fMRI scanner.
Secondary Outcome Measures :
- Quick Inventory of Depressive Symptomatology (QIDS-SR16) [ Time Frame: Baseline vs 1 week post-psilocybin dosing ]Change in QIDS-SR16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 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
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Major depressive disorder (DSM-IV)
- Depression of moderate to severe degree (17+ on the 21-item HAM-D).
- No MRI contraindications
- No SSRI contraindications
- Has a GP (general practitioner) or other mental healthcare professional who can confirm diagnosis
- 18-80 years of age
- Males and females
- Sufficiently competent with English language
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 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
- 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429075
Contacts
| Contact: Bruna Giribaldi | 02075946550 | b.cunha@imperial.ac.uk | |
| Contact: Robin Carhart-Harris | r.carhart-harris@imperial.ac.uk |
Sponsors and Collaborators
Imperial College London
Alexander Mosely Charitable Trust
Investigators
| Principal Investigator: | David J Nutt, Medicine | Imperial College London |
Publications:
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT03429075 History of Changes |
| Other Study ID Numbers: |
17HH3790 2017-000219-18 ( EudraCT Number ) |
| First Posted: | February 12, 2018 Key Record Dates |
| Last Update Posted: | February 12, 2018 |
| Last Verified: | November 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Imperial College London:
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depression mdd major depression major depressive disorder unipolar depression |
psilocybin psychedelics psychedelic escitalopram ssri |
Additional relevant MeSH terms:
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Psilocybin Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Citalopram Dexetimide Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Hallucinogens |