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DepressionPhase 2NCT05594667

Effect of SSRIs on Response to Psilocybin Therapy

A Phase 2 study testing Psilocybin in people with Depression and Major Depressive Disorder, run by Cybin Therapeutics Inc. at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. Read more about this study

Who is it for?
Ages 19 to 65 years
What is being tested?
Psilocybin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
1 Jan 2023to 14 Mar 2023
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 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 19 to 65 years of age
  • Fluent in English
  • Currently receiving treatment with an SSRI (consistent dose for at least 6 weeks), with no changes anticipated throughout the duration of the study
  • QIDS-SR-16 score ≥6
  • Clinically diagnosed Major Depressive Disorder by a psychiatrist prior to screening 5a. Diagnosis defined as meeting the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria (American Psychiatric Association, 2013) for MDD
  • MADRS score 7-34 inclusive (mild-moderate)
Show all 17Show fewer
  • Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
  • Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.
  • Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
  • Agree that for one week before the drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement (specifically SAM-e, 5-HTP, L-tryptophan, St John's Wort) except when approved by the study Investigator. Exceptions will be evaluated by the Investigator and may include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
  • Agree to refrain from consuming alcohol within two days prior to drug administration.
  • Agree not to take any "as needed" medications on the morning of the drug session.
  • Agree to use of highly effective methods of contraception during the study (females)
  • Normal body mass index (BMI 18.5-24.9)
  • Own an Android or iOS device compatible with the fitness tracker software (Apple iOS 13 or higher, Android OS 7.0 or higher)
  • Able to have a friend or family member pick them up after the dosing session
  • Estimated glomerular filtration rate (eGFR) above 40 mL/min/1.73m2 and all other blood-work values Within Normal Limits

Who cannot join

  • Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, dissociative disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anorexia nervosa, bulimia nervosa or substance abuse, as assessed by medical history
  • Currently diagnosed psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain, as assessed by medical history.
  • History of seizures
  • Uncontrolled diabetes, insulin-dependent diabetes, or history of hypoglycemia on oral hypoglycemic agent(s)
  • Paraneoplastic syndrome
  • History of traumatic brain injury within the last 2 years
Show all 17Show fewer
  • Significantly intrusive PTSD as determined by the Investigator
  • Significant suicide risk as defined by C-SSRS within the past two years
  • Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, vascular 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
  • Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc > 450msec), artificial heart valve, or TIA in the past year
  • Psychoactive substance use within the previous two months. 11a. The following criteria are preferred: lifetime total psychoactive substance use less than 10 times.
  • Pregnant, nursing or breastfeeding women. Females of childbearing potential must be on a highly effective or double barrier method of contraception, or abstinent.
  • Participation in another clinical trial (currently or within the last 30 days)
  • Current use of rifamycins (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, taxol, dexamethasone); cytochrome P450 Inhibitors - including all HIV protease inhibitors, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, azithromycin, and troleandomycin; ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl, warfarin, metoprolol, propranolol, buspirone, tramadol, selegiline, sumatriptan.
  • Current use of inhibitors of UGT1A9 and 1A10, monoamine oxidase inhibitors (MAOIs), Tricyclic antidepressants, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs).
  • Use of steroids within the past two weeks.
  • Resting blood pressure >140 mmHg systolic and >90 mmHg diastolic at screening

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Neurology Studies x Upstream

    Abbotsford British Columbia, British Columbia, V2T 2X5

Other trials in Canada

About this study

Official title: Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD)

This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will be enrolled, stratified into four groups:

  • Group 1: ≤ 1 year
  • Group 2: 1 to ≤ 5 years
  • Group 3: 5 to ≤ 10 years
  • Group 4: > 10 years
Read the detailed description

The majority of clinical investigations with psilocybin to date either exclude participants on SSRIs or taper them off SSRIs prior to psilocybin administration. While evidence derived from the use of larger doses of psilocybin suggests that its predominately serotonergic effects are safe when administered in controlled settings, research investigating the effects of psilocybin with individuals taking SSRIs is lacking, despite the prevalent and chronic use of SSRIs in individuals with depression.

The aim of this study is to investigate the effect of length of time on SSRIs on psilocybin-assisted therapy response in individuals with MDD. Specifically, this feasibility study investigates participants who undergo a single-dose of psilocybin (25mg) in combination with pre- and post-dose therapy sessions. The follow-up period in the present study is 12 weeks (3 months).

Being tested
Psilocybin
Keywords
Psilocybin
Medical subject headings
Depression, Depressive Disorder, Major, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

    Also called PEX010

    25mg of psilocybin provided by Filament Health

Study groups in NCT05594667
Study groupRoleWhat they receive
PEX010Experimental25mg of PEX010 (one-time administration)
Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)

    The QIDS-SR16 is a 16-item self-reported rating scale designed to assess severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depression.

    Measured: Baseline to end of study (week 12)

Secondary outcomes (7)

  1. QIDS-SR-16 response

    Defined as a reduction in score of >50%. The QIDS-SR16 is a 16-item self-reported rating scale designed to assess severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depression.

    Measured: Baseline to end of study (week 12)

  2. QIDS-SR-16 remission

    Defined as a score of ≤5. The QIDS-SR16 is a 16-item self-reported rating scale designed to assess severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depression.

    Measured: Baseline to end of study (week 12)

  3. Montgomery and Asberg Depression Rating Scale (MADRS)

    A clinician-rated interview to assess the severity of depression. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60).

    Measured: Baseline to end of study (week 12)

  4. Number of adverse-events (AEs)

    Number of reported AEs

    Measured: Baseline to end of study (week 12)

  5. Number of serious adverse events (SAEs)

    Number of reported SAEs

    Measured: Baseline to end of study (week 12)

  6. Recruitment rate

    Recruitment feasibility will be defined as a minimum recruitment rate of 70% of our target of 30 individuals within 6 months.

    Measured: 6 months

  7. Retention

    Retention feasibility will be defined as a retention rate of 90% at study completion

    Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2022
  2. Study start1 Jan 2023
  3. Primary completion14 Mar 2023
  4. Study completion14 Mar 2023

Why it stopped: Funding

Resources

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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594667
Sponsor's protocol ID
Cybin-001-Depression
Status last verified
Jul 2023
First submitted
19 Oct 2022
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with Depression and Major Depressive Disorder, run by Cybin Therapeutics Inc. at 1 site in Canada.

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 17 inclusion and 17 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: withdrawn, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) (time frame: Baseline to end of study (week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05594667.

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 6 Jul 2023.

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