Evaluating the management of treatment resistant depression with psychedelic (psilocybin) assisted psychotherapy (EMPACT)

Phase 2

• Conditions: Treatment Resistant Depression; Mental Health - Depression

• Registration Number: ACTRN12623001004651
• Lead Sponsor: The Australian National University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-14
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

•Diagnosis of a major depressive episode (MDE) in accordance with the Mini International Neuropsychiatric Interview (MINI)

•Treatment resistant symptoms at Stage II of the Thase and Rush classification: a failure to tolerate minimum of two trials of antidepressant medication at minimum effective therapeutic dose for at least 6 weeks (no exclusion for greater degrees of treatment resistance)

•Moderate – severe depressive symptoms: HAM-D score of >17 (moderate – severe depression)

•Demonstrated capacity to give informed consent

•Willingness and capacity (as judged on assessment by study clinicians) to engage in the therapeutic elements of the study protocol

Exclusion Criteria

•Participants who are not able to give adequate informed consent.

•Current or previously diagnosed psychotic disorder, schizophrenia or bipolar disorder

•Immediate family member with a diagnosed psychotic disorder

•Significant history of mania.

•History of serious suicide attempts in recent years requiring hospitalisation as judged by a study psychiatrist at initial assessment to impact on safety of participation.

•Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g., diagnosis of borderline personality disorder.

•Medically significant condition reviewed as unsuitable for the study due to safety reasons, as reviewed by the study investigator. Such as:
oUnstable diabetes
oModerate – severe hepatic failure
oModerate – severe renal failure
oSevere cardiovascular disease

•Participants presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)

•Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.

•Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.

•Epilepsy

•Moderate to severe previous or current head injury/Traumatic Brain Injury (TBI).

•Have a history of stroke or Transient Ischemic Attack (TIA).

•Current drug or alcohol dependence: Moderate (not in early remission in the 3 months prior to enrolment; meets 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or drug use disorder within the 12 months prior to enrolment (meets at least 6 of 11 diagnostic criteria per DSM-5)

•Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.

•Participants who do not agree to use an acceptable contraceptive method throughout their participation in the study, if applicable.

•Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period.

•Recreational use in last 12 months of psychedelic substances or a history of regular psychedelic use

•No email access/ability or no willingness to engage in follow up by electronic questionnaires

•Use of contraindicated medication (outlined further below) including MAOI, SSRI or SNRI: SSRI/SNRI withdrawal for at least one week (4 weeks for fluoxetine), 2 weeks for irreversible MAOI

•Use within 5 half-lives of any other serotonin-enhancing medication

•Participants with significant difficulties in English comprehension or communication such as to prevent completion of study materials.

•BMI <17 or >42

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continuous scores on the Hamilton Depression Scale (HAM-D) [ From baseline compared to post cycle 1, post cycle 2, post cycle 3 and then 1, 3 and 6 months post the third cycle.]