The Effect of Psilocybin on MDD Symptom Severity... — Clinical Trial Details

Participants

Ages

20 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
Individuals eligible to be randomized in this protocol are those who meet all of the following criteria:
1. Are 20 to 65 years old at the time of written informed consent at the In-Person Screening visit
2. Are able to read, speak, and understand Swedish
3. Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations
4. Are able to swallow capsules
5. Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study, from Screening through the Day 42 assessment
6. Meet ICD-10 criteria for a diagnosis of remitting major depressive disorder and are currently experiencing a major depressive episode of at least 30 days and less than 5 years at time of Screening
7. Have sustained moderate-severe depression symptoms at Screening and Baseline, as defined by a Screening MADRS total score ≥ 22 and ≤30% and ≤7 point improvement from web-screening to screening
9. Have an identified support person and agree to be accompanied home after dosing

Exclusion Criteria

Exclusion Criteria:
1. Women who are pregnant or nursing or intend to become pregnant during the study
2. Current depressive episode lasting >5 years
3. Unwilling or unable to discontinue formal psychotherapy
4. Ongoing antidepressant drug treatment
5. Prior DBS or VNS in current episode
6. Currently receiving ECT or TMS
7. Unable or unwilling to discontinue medications that are UDP or UGT modulators (eg valproate)
8. Report psychedelic substance use ever (psilocybin, LSD, mescaline, DMT, 5-MeO-DMT, ibogaine, 2C compounds, MDMA, etc.)
9. Specific cardiovascular conditions (coronary artery disease, prior MI, long QT, hypertrophy, ischemia, CHF), tachycardia (>100 bpm), clinically significant ECG abnormality (eg QTcF >450 ms), artificial heart valve
10. Elevated blood pressure at Screening or Baseline per protocol thresholds
11. History of stroke or TIA
12. Moderate to severe hepatic impairment (Child-Pugh ≥7)
13. Epilepsy
14. Insulin-dependent diabetes or history of hypoglycaemia requiring intervention
15. Inability to suspend certain medications/supplements (eg PDE5 inhibitors, niacin >20 mg) or positive urine drug test for specified substances
16. Nicotine dependence preventing nicotine-free dosing period
17. ICD-10 schizophrenia spectrum or other psychotic disorders, bipolar I/II or NOS
18. Antisocial personality disorder
19. Moderate or severe alcohol or drug use disorder within past 12 months
20. Any psychiatric condition judged by PI to be more significant than MDD
21. First-degree relative with schizophrenia spectrum/psychotic disorders or bipolar I
22. Psychiatric condition incompatible with rapport or safe exposure to psilocybin
23. Suicidal ideation per MADRS Item 10 ≥5 or any suicidal thoughts judged to present serious risk prior to randomization
24. Any other physical or psychological condition making participant unsuitable

Company

Product

Legal

The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial.

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Niacin (active placebo)

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details