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

NCT05209217 · Mclean Hospital

Closed to entry
Status
Not accepting participants
Not applicable
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

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beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • BOLD fMRI response in amygdala

    Measured over Prior to and 2-3 hours following ketamine administration

  • BOLD fMRI response in posterior insula

    Measured over Prior to and 2-3 hours following ketamine administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

14 Years to 40 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Males and Females * Age 14 - 40 years * Clinical diagnosis of Bipolar Disorder -Fear of Harm Phenotype * Meets Papolos criteria for FOH based on independent interviews. * Taking intranasal ketamine for at least 2 months. * Must be on an every three or every four-day dosing regimen * Dosage will not exceed 300 mg per dosing interval. * Willing to delay ketamine dose by 2 days past their prescribed dosing interval * Prior experience having tolerated this degree of delay. * Willing to participate in daily assessments during period of ketamine withdrawal prior to traveling to Belmont ,MA. * Willing to provide urine sample to screen for drugs of abuse (all participants and pregnancy in females.) Exclusion Criteria: * Any psychiatric hospitalization within the past 6 months * Lifetime history of suicide attempts * Co-occurring substance use disorders * Any change in concomitant medications within the last 2 months

Where

1 study site

FacilityCityRegionCountry
McLean HospitalBelmontMassachusettsUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05209217 on ClinicalTrials.gov →

Last updated in the registry 2022-01-27. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 3 trials from Mclean Hospital →