Open Study of the Neurobiological Effects of Intranasal Ketamine in Children and Adults With Bipolar Disorder

This observational cohort study (n=20), sponsored by Mclean Hospital, investigates the neurobiological effects of intranasal ketamine in children and adults with Bipolar Disorder – Fear of Harm Phenotype (FOH).

The study aims to test several hypotheses related to the response to ketamine in this population. Participants, aged 14 to 40 years, will be recruited based on their clinical diagnosis of Bipolar Disorder – FOH Phenotype and their history of using intranasal ketamine for at least two months.

The study will assess various outcomes, including amygdala response to threatening stimuli, EEG spectral activity, and functional connectivity between brain regions before and after ketamine administration. The primary completion date is estimated to be December 2022, with a total estimated enrollment of 20 participants.

The study will be conducted at Mclean Hospital in Belmont, Massachusetts, United States.

Topic Bipolar Disorder Depression
Compound Ketamine
Country United States of America
Visit trial
Status Unknown status
Results Published No
Start date 04 June 2019
End date 15 January 2023
Phase Not Applicable
Design Open
Type Observational
Generation First
Participants 20
Sex All
Age 14- 40
Therapy No

Trial Details

Aim 1: Test the hypothesis that participants with Bipolar Disorder - Fear of Harm Phenotype have an enhanced amygdala fMRI response to fearful threatening stimuli, increased resting beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine. Aim 2. Test the hypothesis that ketamine alters response to fearful-threatening visual stimuli and cold sensation by altering functional connectivity of the amygdala and insula with the hypothalamus, thalamus, hippocampus and ventromedial prefrontal cortex, and identify specific alterations that correlate with degree of pre-post ketamine change. Aim 3. Test the hypothesis that low-dose medicinal ketamine, unlike high-dose recreation ketamine, is not associated with an increase in number of focal areas of abnormality on morphometric scans based on duration of use.

Trial Number NCT05209217

Sponsors & Collaborators

Mclean Hospital
McLean Hospital is a psychiatric hospital in Belmont, Massachusetts. The hospital maintains the world's largest neuroscientific and psychiatric research program in a private hospital.

Data attribution

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