Synaptic Imaging and Network Activity in Treatment Resistant Depression (SIGNATURE)

This double-blind active-placebo crossover trial (n=50) conducted by King’s College London aims to investigate the effects of ketamine (35mg/70kg) on the functional connectivity of the brain in individuals with treatment-resistant depression (TRD).

Participants will receive three separate IV infusions of ketamine (0.5mg/kg) followed by three separate IV infusions of an active placebo (midazolam (0.045mg/kg)), or 3 IV infusions of midazolam followed by 3 IV infusions of ketamine, in a randomised crossover design. The study will involve 11 visits, including baseline assessments, MRI and EEG scans, and cognitive and clinical assessments.

The primary outcome measure will be changes in resting-state functional magnetic resonance imaging (fMRI) connectivity, while secondary outcome measures include changes in fMRI task-based activity, blood biomarkers related to synaptogenesis, and cognitive performance.

Participants must be aged between 18 and 55, diagnosed with major depressive disorder (MDD), bipolar 1 or bipolar 2 depression, and have moderate to severe depression symptoms. Exclusion criteria include current or previously diagnosed psychotic disorders, previous adverse responses to ketamine or midazolam, and various medical conditions. The study is expected to start in October 2021 and conclude in September 2023.

Topic Depression Treatment-Resistant Depression Bipolar Disorder
Country United Kingdom
Visit trial
Status Recruiting
Results Published No
Start date 20 October 2021
End date 11 September 2023
Phase Not Applicable
Design Blinded
Type Interventional
Generation First
Participants 50
Sex All
Age 18- 55
Therapy No

Trial Details

The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD). This study will investigate the relationship between these changes and response to treatment as measured by clinical scales, as well as examining drug induced changes in reward and emotion based brain activity, structural connectivity, cerebral blood flow, cognition, metabolism and blood markers of brain plasticity.

Trial Number NCT05870501

Sponsors & Collaborators

King's College London
The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London is one of Europe's top centres for mental health and related neurosciences research.

Data attribution

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