A phase II randomized, double-blind, active... — Clinical Trial Details

Participants

Ages

25 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

1) Aged 25–65 years.
2) Major depressive disorder (single or recurrent) of moderate to severe degree without psychotic features (DSM-5); ICD-10: F32.1, F32.2, F33.1, F33.2.
3) HAM-D score ≥ 17.
4) Treatment-resistant as defined by lack of adequate improvement after two adequate antidepressant courses (≥6 weeks each) of different classes; augmentation counts as a second treatment.
5) Discontinuation of monoaminergic psychiatric medication for at least 2 weeks prior to dosing (fluoxetine: 5 weeks) or supervised down-titration.
6) Abstinent from alcohol (BAC 0.00) and negative urine drug screen on dosing day.
7) Medically stable by labs, vitals and 12-lead ECG (QTcF ≤450 ms males, ≤470 ms females; PR <220 ms) or acceptable per investigator.
8) Willing and able to adhere to protocol restrictions and provide informed consent.

1) Current or prior DSM-5 diagnosis of: depressive episode with psychotic features; schizophrenia spectrum or other primary psychotic disorders; bipolar disorder; cluster A personality disorders and/or borderline personality disorder (assessed with SCID-5-PD); PTSD.
2) First-degree family history of psychosis and/or bipolar disorder.
3) Current or recent clinically significant suicidal ideation within past 6 months (C-SSRS score 4–5) or suicidal behaviour within past 1 year; prior attempts or serious ideation >6 months require careful screening and investigator discretion.
4) Current comorbid psychiatric diagnoses (except the index MDD) as specified under exclusion 1; substance use disorder (except tobacco/caffeine). Alcohol consumption >40 g/day men or >20 g/day women excluded.
5) Use of classical psychedelics in past year or >5 lifetime uses.
6) Failure to establish sufficient rapport with therapists after first two preparation sessions.
7) Lithium intake.
8) ECT within 12 months or ketamine/esketamine within 6 months prior to screening.
9) Prior vagal nerve stimulation or deep brain stimulation.

A phase II randomized, double-blind, active placebo-controlled parallel group trial to examine the efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE)