Treatment Resistant DepressionPhase 2NCT04739865
The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression
A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression, run by COMPASS Pathways at 2 sites in 2 countries.
Trial summary
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Aug 2020to 14 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed ICF.
- 18 years of age or older
- At least moderate MDD
- Hamilton Depression Rating Scale (17 item) score ≥18
- Currently receiving treatment with a selective serotonin reuptake inhibitor
- Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments
- McLean Screening Instrument for Borderline Personality Disorder <7 at Screening (V1).
- Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Who cannot join
- Psychiatric Exclusion Criteria:
- Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history, McLean Screening Instrument for Borderline Personality Disorder and a structured clinical interview (version 7.0.2 MINI).
- Prior electroconvulsive therapy and/or ketamine for current episode.
- Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI
- Current psychological therapies that will not remain stable within 21 days of the psilocybin session. Psychological therapies cannot be initiated within 21 days of baseline.
- Current (within the last year) alcohol or substance use disorder as informed by DSM 5 (diagnosed by MINI 7.0.2) at Screening (V1).
Show all 19Show fewer
- Significant suicide risk as defined C-SSRS within the past year
- Depression secondary to other severe medical conditions according to clinicians' judgement.
- Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin, including exposure to psilocybin within the past year and use of psychedelics, such as ayahuasca, during the current depressive episode.
- General Medical Exclusion Criteria:
- Women who are pregnant, nursing or planning a pregnancy.
- Cardiovascular conditions
- Uncontrolled or insulin dependent diabetes.
- Seizure disorder.
- Positive urine drug screen for illicit drugs or drugs of abuse
- Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening (V1).
- Current enrolment in another clinical study of an investigational medical or participation in such within 30 days of Screening (V1).
- Abnormal and clinically significant results on the physical examination, vital signs, ECG or laboratory tests at Screening (V1).
- Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
About this study
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression
Read the detailed description
A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40% of participants sustained response at 3 months. In this study, the aim is to explore effectiveness of 25 mg of psilocybin as an adjunctive therapy in participants with TRD.
- Conditions
- Treatment Resistant Depression
- Being tested
- Psilocybin
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called COMP360
Open label
| Study group | Role | What they receive |
|---|---|---|
| 25 mg COMP360 Psilocybin | Experimental | 25 mg COMP360 Psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Depressive Symptoms
Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to 3 weeks post psilocybin administration.
The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
Measured: 3 weeks
Secondary outcomes (3)
Incidence of Response
The proportion of participants with a response (defined as a ≥ 50% improvement in Montgomery-Asberg Depression Rating Scale [MADRS] total score from Baseline) at Week 3 post psilocybin administration.
The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
Measured: 3 weeks
Incidence of Remission
The proportion of participants with remission (defined as Montgomery-Asberg Depression Rating Scale [MADRS] total score ≤ 10) at Week 3 post psilocybin administration The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
Measured: 3 weeks
Improvement in Clinical Global Impression - Severity
Changes from Baseline in Clinical Global Impression-Severity score at Week 3 post psilocybin administration.
The minimum and maximum values are 1 and 7 and a higher score means a worse outcome.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start10 Aug 2020
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment Resistant 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- COMPASS Pathways
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Goodwin, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739865
- Sponsor's protocol ID
- COMP003
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2020
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT04739865
- Acronym / sponsor ID
- COMP003
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- COMPASS PathwaysIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression
Detailed description
A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40% of participants sustained response at 3 months. In this study, the aim is to explore effectiveness of 25 mg of psilocybin as an adjunctive therapy in participants with TRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| 25 mg COMP360 Psilocybin | Experimental | Drug: Psilocybin25 mg COMP360 Psilocybin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed ICF.
- 18 years of age or older
- At least moderate MDD
- Hamilton Depression Rating Scale (17 item) score ≥18
- Currently receiving treatment with a selective serotonin reuptake inhibitor
Key exclusion criteria (19 listed)
- Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history, McLean Screening Instrument for Borderline Personality Disorder and a structured clinical interview (version 7.0.2 MINI).
- Prior electroconvulsive therapy and/or ketamine for current episode.
- Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI
- Current psychological therapies that will not remain stable within 21 days of the psilocybin session. Psychological therapies cannot be initiated within 21 days of baseline.
- Current (within the last year) alcohol or substance use disorder as informed by DSM 5 (diagnosed by MINI 7.0.2) at Screening (V1).
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 |
|---|---|---|
| PsilocybinAlso: COMP360Open label | Drug | 25 mg COMP360 Psilocybin |
Primary outcome
Improvement in Depressive Symptoms
Time frame: 3 weeks
Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to 3 weeks post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
3 secondary outcomes
Incidence of Response
Time frame: 3 weeks
Incidence of Remission
Time frame: 3 weeks
Improvement in Clinical Global Impression - Severity
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Guy Goodwin principal investigator
University of Oxford
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression, run by COMPASS Pathways at 2 sites in 2 countries.
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 8 inclusion and 19 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: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 9 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Depressive Symptoms (time frame: 3 weeks). 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 9 Nov 2023.