Oral Ketamine Trial on people aged 16 years and older with Treatment-Resistant Depressio

Phase 2

Recruiting

• Conditions: Treatment-Resistant Depression; Mental Health - Depression

• Registration Number: ACTRN12621000429853
• Lead Sponsor: Thompson Institute, University of the Sunshine Coast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-16
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

•Patients who suffer from TRD and determined by cut-off scores of: 17 for the HAM-D
•Persons (male/female/other) aged 16 years and over
•Participants must be able to understand the Participant Information Form (PIF) and provide written informed consent on the Participant Consent Form (PCF)

Exclusion Criteria

Demographic
•Persons under 16 years of age
Psychiatric conditions
•Psychosis
•Mania/hypomania
•Acute suicidality requiring urgent psychiatric intervention
•History of ketamine use disorder
•Recovery from a substance use disorder within prior 6 months

Physical conditions
•Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100)
•History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure (as assessed by referring general practitioner)
•Liver function test (LFT) results out of normal range, as specified below:
•ALT: >135 U/L
•AST: >123 U/
•GAMMA GT (GGT) male participants: >210 U/L
•GAMMA GT (GGT) – female participants: >135 U/L
•TOTAL BILIRUBIN (BIT): >60 umol/L
•ALBUMIN (A): <25g/L and >150g/L
•ALK PHOS (ALP): >345 U/L
•Previous reaction to ketamine (as reported by referring general practitioner and participant)
•Pregnant women
•Breastfeeding women
•History of epilepsy or unexplained seizures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinician-rated depressive symptomatology will be assessed using the Hamilton Depression Rating Scale (HAM-D), [ The HAM-D will be administered at the following time points: • Baseline (week 0) • 30-60 minutes pre-ketamine treatment • Follow-up 1 (1 week after final ketamine treatment) (primary endpoint) • Follow-Up 2 (2 weeks after final ketamine treatment)];Participant-rated depression symptoms will be measured using the Inventory of Depressive Symptomatology Self-Rating (IDS-SR) as the primary outcome measure in this project. [ The IDS-SR will be administered at the following time points: • Baseline (week 0) • 30-60 minutes pre-ketamine treatment • 30-60 minutes after ketamine treatment • Phone call one: 24 hours post-ketamine treatment • Phone call two: +4-5 days post-ketamine treatment • Follow-up 1 (1 week after final ketamine treatment) (primary endpoint) • Follow-up 2 (2 weeks after final ketamine treatment)]