Post-traumatic Stress DisorderPhase 2SUMMIT-90NCT06141876
Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD
A Phase 2 study testing APEX-002-A02 in people with Post-traumatic Stress Disorder and Depression, run by Apex Labs Ltd..
Trial summary
Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder, Depression
- What is being tested?
- APEX-002-A02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 15 Jun 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals between 18 and 65 years of age, inclusive, at the time of consent.
- Individuals who are fluent in the language of the study site, specifically English or French.
- Meet DSM-5 criteria for current PTSD with presence of symptoms for at least 6 months at screening.
- Participant must have at least moderate PTSD, as scored as ≥35 on the CAPS-5 scale at screening.
- Participant must have severe depression, as scored as ≥30 on the BDI-II scale at screening.
- If individuals are on psychotropic medications, they must be on stable doses (no dosing adjustments/changes for ≥4 weeks) prior to beginning of the study and for the duration of the study.
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- If individuals are users of psychoactive substances, including alcoholic beverages, tobacco, and cannabis, they must remain on stable doses for the duration of the study.
- For individuals of childbearing potential involved in any sexual intercourse that could lead to pregnancy: willing to use adequate birth control to prevent pregnancy (in participant or partner) for the entire duration of the study.
- Capable of providing ongoing, signed informed consent.
- Available for the duration of the study, and able and willing to comply with all study procedures, including completion of questionnaires.
- Agree to identify a local contact person to the research team, that is available over the entire course of the subject's participation in the study to act as an emergency contact.
Who cannot join
- Female subject that is pregnant, is planning or suspected to become pregnant, or is lactating.
- Known or suspected hypersensitivity or contraindication to psilocybin or any constituents or excipients of the study drug.
- Abnormal and clinically significant results on the physical examination, vital signs, ECG or laboratory tests at screening.
- Presence of any unstable medical condition or neurological illness, in the opinion of the Investigator.
- History of clinically significant cardiovascular disease including but not limited to stroke, myocardial infarction or clinically significant arrhythmia (in the past 1 year).
- Indication of inadequately treated current hypertension (resting systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg) at screening.
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- If a subject is being treated with inhibitor(s) of UGT1A9, UGT1A10, monoamine oxidase (MAO), aldehyde dehydrogenase (ALDH), or alcohol dehydrogenase (ADH) they should be discontinued at least five half lives prior to administration of study drug.
- Lifetime history of psychosis-related disorder or bipolar disorder (I or II).
- Subject has 1st degree relative(s) with schizophrenia or bipolar disorder.
- At the time of screening, any condition other than PTSD judged to be the primary presenting psychiatric diagnosis, in the opinion of the Investigator.
- Clinical diagnosis of dementia or any physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the patient reported outcomes.
- History of any other clinically significant 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.
- Individuals who present a current risk to themselves or others, as assessed by the Investigator. This includes, but is not limited to:
- Active suicidal ideation with specific plan and intent in the past 1 month, as assessed with the C-SSRS at screening.
- History of suicidal behavior (actual attempt, interrupted attempt, aborted or self-interrupted attempt, preparatory acts or behavior) in the past 3 months, as assessed with the C-SSRS at screening.
- Any prior suicidal ideation/behavior that, per the Investigator's judgment, makes the participant unsuitable for the study.
- Current active Substance Use Disorder or Alcohol Use Disorder, as assessed by the Investigator via medical screening.
- Individuals with other personal circumstances and behaviour judged to impact safety (risk and not be able to adhere to the protocol requirements).
- Individuals with significant prior exposure to psilocybin, defined as:
- Chronic use (>10 exposures) of psilocybin in any form and at any dose in the past year; OR
- Any use of psilocybin within 4 weeks prior to screening; OR
- Any previous use of psilocybin for PTSD or related symptoms, including depression, that was discontinued due to lack of effect, as judged by the individual or their treating physician.
- Self reported use within 12 weeks prior to screening of (i) classical psychedelics other than psilocybin (LSD, mescaline, dimethyltryptamine); (ii) MDMA; (iii) ketamine, and; (iv) dextromethorphan.
- Actively participating in other interventional clinical trial(s).
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder (PTSD).
Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence. Exposure to a traumatic event is defined as directly experiencing the event, learning about the event, or repeated exposure to details of the event. PTSD is often accompanied by other psychiatric and physical comorbidities, both of which are associated with elevated healthcare costs. Depression, psychosis and suicide rates are consistently reported in greater proportion of PTSD patients. Despite the overwhelming impact of PTSD and comorbid depression, there is a shortfall of effective treatments with few side effects that target the broad range of symptoms, including depression.
Psilocybin has been studied for the treatment of depression, anxiety, tobacco and alcohol use disorders, obsessive-compulsive disorder, end of life depression and anxiety, demonstrating safety and efficacy for a variety of indications, with no significant adverse events occurring during the course of treatment and follow-up. Notably, in a participant group distinguished by long-standing, moderate to severe major depressive disorder, two doses of psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6 weeks of daily escitalopram, a commonly used SSRI. Promising results found in these studies have led to psilocybin recently receiving breakthrough designation from the US FDA for its potential therapeutic effect in the treatment of depression.
Based on previous research, psilocybin has demonstrated a favorable safety profile and has shown preliminary efficacy against depression as well as other symptoms that typically affect patients with PTSD. Unlike traditional SSRIs which are associated with treatment-resistance and addiction, psilocybin requires few doses to improve a wide-range of symptoms and has not been linked with physical dependence. Furthermore, the effect of other psychedelics can vary greatly and may potentially exacerbate existing conditions.
- Conditions
- Post-traumatic Stress Disorder, Depression
- Being tested
- APEX-002-A02, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APEX-002-A02Drug
Also called psilocybin
Active
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | APEX-002-A02 Receives: Drug: APEX-002-A02 |
| Placebo | Placebo comparator | matched placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Treatment emergent AEs and SAEs
Measured: Baseline to Day 140
Number of participants with abnormal vital signs, abnormal physical exam findings, abnormal ECG, and abnormal laboratory tests results
Measurements: vital signs, physical exam, ECG, and laboratory tests
Measured: Baseline to Day 140
Change in severity of depressive symptoms
Assessed by total score of Beck Depression Inventory (BDI-II); 21-items scale. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: Baseline to Day 77
Secondary outcomes (5)
Change in severity of depressive symptoms
Assessed by total score of Beck Depression Inventory (BDI-II); 21-items scale. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: Baseline to Days 21, 49, and 140
Change in severity of PTSD symptoms
Assessed by total score of Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5); 30-item questionnaire. Severity rating: 0=absent, 1-mild/sub-threshold, 2-moderate/threshold, 3-severe/markedly elevated, 4-extreme/incapacitating.
Measured: Baseline to Days 21, 49, 77 and 140
Change in severity of anxiety
Assessed by Beck Anxiety Inventory (BAI); 21-item scale. BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).
Measured: Baseline to Days 21, 49, 77 and 140
Change in presence and severity of suicidal ideation and behaviour
Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); 10-category scale with binary (yes/no) responses. There are no specified clinical cutoffs for the C-SSRS due to the binary nature of the responses to items. When an item is endorsed ("yes"), the clinician must pose follow-up inquiries to obtain additional information.
Measured: Baseline to Days 21, 49, 77 and 140
Change in chronic pain severity
Assessed by Brief Pain Inventory (BPI); 9-point questionnaire with 0-10 scale for each point; 0=no pain, 10=pain as bad as you can imagine.
Measured: Baseline to Days 21, 49, 77 and 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start15 Dec 2023 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apex Labs Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141876
- Sponsor's protocol ID
- APEX-002-A02-01
- Acronym
- SUMMIT-90
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder (PTSD).
- ClinicalTrials.gov ID
- NCT06141876
- Acronym / sponsor ID
- SUMMIT-90 / APEX-002-A02-01
- Conditions
- Post-traumatic Stress Disorder, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Apex Labs Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 21 Nov 2023 (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.
Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence. Exposure to a traumatic event is defined as directly experiencing the event, learning about the event, or repeated exposure to details of the event. PTSD is often accompanied by other psychiatric and physical comorbidities, both of which are associated with elevated healthcare costs. Depression, psychosis and suicide rates are consistently reported in greater proportion of PTSD patients. Despite the overwhelming impact of PTSD and comorbid depression, there is a shortfall of effective treatments with few side effects that target the broad range of symptoms, including depression.
Psilocybin has been studied for the treatment of depression, anxiety, tobacco and alcohol use disorders, obsessive-compulsive disorder, end of life depression and anxiety, demonstrating safety and efficacy for a variety of indications, with no significant adverse events occurring during the course of treatment and follow-up. Notably, in a participant group distinguished by long-standing, moderate to severe major depressive disorder, two doses of psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6 weeks of daily escitalopram, a commonly used SSRI. Promising results found in these studies have led to psilocybin recently receiving breakthrough designation from the US FDA for its potential therapeutic effect in the treatment of depression.
Based on previous research, psilocybin has demonstrated a favorable safety profile and has shown preliminary efficacy against depression as well as other symptoms that typically affect patients with PTSD. Unlike traditional SSRIs which are associated with treatment-resistance and addiction, psilocybin requires few doses to improve a wide-range of symptoms and has not been linked with physical dependence. Furthermore, the effect of other psychedelics can vary greatly and may potentially exacerbate existing conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: APEX-002-A02APEX-002-A02 |
| Placebo | Placebo comparator | Other: Placebomatched placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals between 18 and 65 years of age, inclusive, at the time of consent.
- Individuals who are fluent in the language of the study site, specifically English or French.
- Meet DSM-5 criteria for current PTSD with presence of symptoms for at least 6 months at screening.
- Participant must have at least moderate PTSD, as scored as ≥35 on the CAPS-5 scale at screening.
- Participant must have severe depression, as scored as ≥30 on the BDI-II scale at screening.
Key exclusion criteria (24 listed)
- Female subject that is pregnant, is planning or suspected to become pregnant, or is lactating.
- Known or suspected hypersensitivity or contraindication to psilocybin or any constituents or excipients of the study drug.
- Abnormal and clinically significant results on the physical examination, vital signs, ECG or laboratory tests at screening.
- Presence of any unstable medical condition or neurological illness, in the opinion of the Investigator.
- History of clinically significant cardiovascular disease including but not limited to stroke, myocardial infarction or clinically significant arrhythmia (in the past 1 year).
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 |
|---|---|---|
| APEX-002-A02Also: psilocybinActive | Drug | Active |
| Placeboplacebo | Other | Placebo |
Primary outcome
Incidence of adverse events
Time frame: Baseline to Day 140
Treatment emergent AEs and SAEs
Number of participants with abnormal vital signs, abnormal physical exam findings, abnormal ECG, and abnormal laboratory tests results
Time frame: Baseline to Day 140
Measurements: vital signs, physical exam, ECG, and laboratory tests
Change in severity of depressive symptoms
Time frame: Baseline to Day 77
Assessed by total score of Beck Depression Inventory (BDI-II); 21-items scale. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
5 secondary outcomes
Change in severity of depressive symptoms
Time frame: Baseline to Days 21, 49, and 140
Change in severity of PTSD symptoms
Time frame: Baseline to Days 21, 49, 77 and 140
Change in severity of anxiety
Time frame: Baseline to Days 21, 49, 77 and 140
Change in presence and severity of suicidal ideation and behaviour
Time frame: Baseline to Days 21, 49, 77 and 140
Change in chronic pain severity
Time frame: Baseline to Days 21, 49, 77 and 140
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APEX-002-A02 in people with Post-traumatic Stress Disorder and Depression, run by Apex Labs Ltd..
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 11 inclusion and 24 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 29 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
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?
Incidence of adverse events (time frame: Baseline to Day 140). The study lists 3 primary outcomes in all. 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 29 Nov 2023.