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Ketamine Clinical Trials

Open Study of the Neurobiological Effects of Intranasal Ketamine in Children and Adults With Bipolar Disorder - Fear of Harm Phenotype

To see complete record on clinicaltrials.gov, please visit this link

Id: NCT05209217

Organisation Name: Mclean Hospital

Overal Status: Recruiting

Start Date: June 4, 2019

Last Update: January 27, 2022

Lead Sponsor: Mclean Hospital

Brief Summary: 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beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.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.

• Bipolar Disorder