Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)
- Conditions
- Treatment Resistant Depression (TRD)Mental Health - Depression
- Registration Number
- ACTRN12624000040561
- Lead Sponsor
- Dr and A/ Professor Ranil Gunewardene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Must suffer from TRD
(1) Is not able to give adequate informed consent, or is under 18 or over 65 years old.
(2) Has uncontrolled hypertension or unstable diabetes.
(3) Has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula)1
(4) Has a history of additional risk factors for Torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
(5) Has evidence or history of significant medical disorders e.g. epilepsy, stroke, unstable cardio vascular disease
(6) Has symptomatic liver disease.
(7) Has a history of hyponatremia or hyperthermia.
(8) Weighs less than 48 kg.
(9) Is pregnant or nursing or is of childbearing age and is not practicing an effective means of birth control.
10) Is currently abusing illegal drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in clinician rated depression severity[Change in Montgomery–Åsberg Depression Rating Scale (MADRS) from baseline baseline and 2 weeks post treatment ]
- Secondary Outcome Measures
Name Time Method