An open-label clinical trial of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist on depressive symptomatology in people aged 16 years and older who are experiencing treatment-resistant depression

This open-label trial (n=25-50) investigates the effects of low-dose oral ketamine on depressive symptomatology in individuals aged 16 years and older diagnosed with treatment-resistant depression (TRD).

Administered once a week over a 6-week period, participants will receive liquid oral ketamine at doses ranging from 0.5mg to 3.0mg per kilogram of bodyweight. The trial, conducted at the Thompson Institute, University of the Sunshine Coast in Australia, aims to explore the feasibility, tolerability, and safety of this intervention.

The primary outcome measures include clinician-rated and participant-rated depression symptoms, assessed using the Hamilton Depression Rating Scale (HAM-D) and the Inventory of Depressive Symptomatology Self-Rating (IDS-SR) respectively. Secondary outcomes encompass neurobiological effects, psychiatric side effects, suicidality, social and occupational functioning, anxiety, stress, depression, global wellbeing, changes in neural network communication, cognitive functioning, and clinical side effects.

The trial, which began in March 2021 and anticipates completion by May 2024, is led by Dr. Adem Can and funded by the Thompson Institute, University of the Sunshine Coast.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 02 March 2021
End date 30 May 2024
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 25
Sex All
Age 16- 99
Therapy No

Trial Details

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.

Trial Number ACTRN12621000429853

Sponsors & Collaborators

University of the Sunshine Coast
The Thompson Institute at the University of the Sunshine Coast focuses on mental health research, training, and treatment, integrating neuroscience to uncover insights into mental health and its connection to brain structure and function.

Data attribution

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