Effect of SSRIs on Response to Psilocybin Therapy

NCT05594667 | Withdrawn Phase 2

• 1 other identifier: Cybin-001-Depression
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Depression; Major Depressive Disorder; Mild Depression; Moderate Depression; Depressive Disorder

Keywords

Psilocybin

Outcome Measures

Primary Outcomes (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.

  Baseline to end of study (week 12)

Secondary Outcomes (7)

• QIDS-SR-16 response

  Baseline to end of study (week 12)

• QIDS-SR-16 remission

  Baseline to end of study (week 12)

• Montgomery and Asberg Depression Rating Scale (MADRS)

  Baseline to end of study (week 12)

• Number of adverse-events (AEs)

  Baseline to end of study (week 12)

• Number of serious adverse events (SAEs)

  Baseline to end of study (week 12)

Other Outcomes (6)

• Electroencephalography (EEG) - Response size of select ERPs (N100, P300, N400)

  Baseline to end of study (week 12)

• Electroencephalography (EEG) - Response timing of select ERPs (N100, P300, N400)

  Baseline to end of study (week 12)

• Heart rate variability

  1 month (week -2 to week +2)

Study Arms (1)

PEX010

EXPERIMENTAL

25mg of PEX010 (one-time administration)

Drug: Psilocybin

Interventions

Psilocybin DRUG

25mg of psilocybin provided by Filament Health

Also known as: PEX010

PEX010

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Cybin Therapeutics Inc.: lead

Study Sites (1)

Centre for Neurology Studies x Upstream

Abbotsford, British Columbia, V2T 2X5, Canada

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Reginald Peters, MD

  Upstream

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 26, 2022
• Study Start: January 1, 2023
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)