Shortened LSD Intervention for Major Depressive... — Clinical Trial Details | Blossom

Shortened LSD Intervention for Major Depressive... — Clinical Trial Details | Blossom

Inclusion Criteria

Have given written informed consent
Meet DSM-5 criteria for MDD
MADRS \>= 28 at screening Can read, write, and speak English fluently
Be judged by study team clinicians to be at low risk for suicidality

Exclusion Criteria

Women who are pregnant, nursing, or not practicing an effective means of birth control
Cardiovascular conditions: hypertension with resting blood pressure systolic \>139 or diastolic \>89, angina, heart rate \> 99, a clinically significant ECG abnormality (e.g., atrial fibrillation, QTc \> 450), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease, cardiac valvulopathy
Epilepsy
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Currently taking antipsychotics, or MAO inhibitors
Patients taking antidepressant medications and unable to taper
Moderate or strong CYP2D6 inhibitor antidepressants must undergo a washout period of 4 weeks or five half-lives prior to treatment
Currently taking CYP2D6 inhibitor other than an antidepressant that will be tapered
Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag
Have a seizure disorder, multiple sclerosis, history of significant head trauma, CNS tumor, movement disorders or any neurodegenerative condition
Morbidly obese (\>100 lbs. above ideal body weight, or BMI \>=40, or BMI \>=35 with high blood pressure or diabetes)
Be judged by a study team clinician to be at risk for moderate or severe alcohol or benzodiazepine withdrawal
Body weight \< 45 kg
Significant acute adverse reaction (e.g., dystonia) to an antipsychotic
Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (including substance-induced), Bipolar I or II Disorder or Major
Depression with psychotic features
Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or Bipolar I Disorder.