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

Conditions

None listed

Brief summary

This study is an open-label, dose-ranging clinical trial aiming to explore the feasibility, tolerability, and safety of low-dose oral ketamine on treatment-resistant depression. In this 8-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments. Additionally to any changes in depressive symptomatology, this study will determine whether the intervention improves rates of anxiety, stress, suicidality, and social and occupational functioning. The study will also explore neurobiological effects of oral ketamine, assessing the treatment mechanisms of action and identifying predictors of response.

Related papers

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Interventions

This study is an open-label, dose-ranging clinical trial aiming to explore the feasibility, tolerability, and safety of low-dose oral ketamine on treatment-resistant depression. In this 8-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments. Participants (N = 25-50) will receive low-dose liquid oral ketamine (OK) in water or flavoured drink once a week over a 6-week period (6 OK treatments in total). The initial dose will be 0.5mg per kilogram of

This study is an open-label, dose-ranging clinical trial aiming to explore the feasibility, tolerability, and safety of low-dose oral ketamine on treatment-resistant depression. In this 8-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments. Participants (N = 25-50) will receive low-dose liquid oral ketamine (OK) in water or flavoured drink once a week over a 6-week period (6 OK treatments in total). The initial dose will be 0.5mg per kilogram of bodyweight, after which dose will be increased by 0.1mg – 1.0mg/kg in each treatment, with a maximum dose of 3.0mg/kg. Oral ketamine will be administered on-site by the psychiatrist as per the dosage protocol on routine basis but can be administered by the mental health nurse practitioner as directed by the psychiatrist. The participants will be observed at Thompson Institute for up to two hours after the drug administration. An accountability logbook and controlled drug register (as per Queensland Governmental regulations) for ketamine will be maintained throughout the trial. If a participant is unable to attend or misses a ketamine treatment, details of the deviation will be recorded in the source documentation. Participants will be withdrawn from the study if they miss more than 2 ketamine treatments.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

No

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

Outcome results