Severe DepressionPhase 2Psilo101NCT03380442
Psilocybin and Depression
A Phase 2 study testing Psilocybin and Ketamine (Ketalar) in people with Severe Depression, run by University of Helsinki.
Trial summary
The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Severe Depression
- What is being tested?
- Psilocybin and Ketamine (Ketalar)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).
- No health-related contraindications.
Who cannot join
- 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 suicide attempts.
- History of mania.
- Current 5-HT2A antagonist antidepressant medication.
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- Blood or needle phobia.
- Positive pregnancy test.
- Current drug or alcohol dependence.
- Lack of appropriate use of contraception.
- Breast-feeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression
The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.
- Conditions
- Severe Depression
- Being tested
- Psilocybin, Ketamine (Ketalar)
- Keywords
- fMRI, psilocybin, ketamine, biomarker, rapid-acting antidepressants
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin ingested orally
Ketamine (Ketalar)Drug
Ketamine administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin group | Experimental | This group will receive a single oral 25mg dose of psilocybin under surveilled and safe conditions. Receives: Drug: Psilocybin |
| Ketamine group | Active comparator | This group will receive a single intranasal 125mg dose of ketamine under surveilled and safe conditions. Receives: Drug: Ketamine (Ketalar) |
| No-treatment group | No intervention | This group will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)
The primary outcome measures in this study will be the mean change in QIDS scores from pre-administration baseline at day 1 to Follow-up 2 at day 103 (3 months after the administration session). Additionally, an electronic version of the QIDS will be performed 6 months after the administration session. The criteria for determining response will be a reduction of 25% in the (QIDS; Rush et al., 2003) scores from baseline (screening), and remission will be scores of ≤5 on the QIDS.
Measured: 6 months
Secondary outcomes (2)
The Montgomery and Asberg Depression Rating Scale
The Montgomery and Asberg Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).
Measured: 3 months
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study startSep 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a randomized, double-blind placebo-controlled design, 20 of the participants will receive ketamine, and 20 will receive psilocybin. 20 of the participants will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified. The no-treatment group will only attend the initial clinical interviews, and their depressive symptoms will be assessed remotely.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki, Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK
- Responsible party
- Principal investigator, Jesper Ekelund, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380442
- Sponsor's protocol ID
- 2016-004195-22
- Other IDs
- 2016
- Acronym
- Psilo101
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression
- ClinicalTrials.gov ID
- NCT03380442
- Acronym / sponsor ID
- Psilo101 / 2016-004195-22
- Conditions
- Severe Depression
- Keywords
- fMRI, psilocybin, ketamine, biomarker, rapid-acting antidepressants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki, Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- In a randomized, double-blind placebo-controlled design, 20 of the participants will receive ketamine, and 20 will receive psilocybin. 20 of the participants will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified. The no-treatment group will only attend the initial clinical interviews, and their depressive symptoms will be assessed remotely.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin group | Experimental | Drug: PsilocybinThis group will receive a single oral 25mg dose of psilocybin under surveilled and safe conditions. |
| Ketamine group | Active comparator | Drug: Ketamine (Ketalar)This group will receive a single intranasal 125mg dose of ketamine under surveilled and safe conditions. |
| No-treatment group | No intervention | –This group will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).
- No health-related contraindications.
Key exclusion criteria (11 listed)
- 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 suicide attempts.
- History of mania.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinPsilocybin ingested orally | Drug | Psilocybin group |
| Ketamine (Ketalar)Ketamine administered intranasally | Drug | Ketamine group |
Primary outcome
The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: 6 months
The primary outcome measures in this study will be the mean change in QIDS scores from pre-administration baseline at day 1 to Follow-up 2 at day 103 (3 months after the administration session). Additionally, an electronic version of the QIDS will be performed 6 months after the administration session. The criteria for determining response will be a reduction of 25% in the (QIDS; Rush et al., 2003) scores from baseline (screening), and remission will be scores of ≤5 on the QIDS.
2 secondary outcomes
The Montgomery and Asberg Depression Rating Scale
Time frame: 3 months
Hamilton Depression Rating Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin and Ketamine (Ketalar) in people with Severe Depression, run by University of Helsinki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona E Moisala, PhD (504480044 ext. +358, mona.moisala@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 16-Item Quick Inventory of Depressive Symptomatology (QIDS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.