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

NCT05209217 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2022-01-27

No results posted yet for this study

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beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.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

Conditions

Interventions

DRUG

Ketamine

Intranasal administration of their customary prescribed dose

Sponsors & Collaborators

  • Juvenile Bipolar Research Foundation

    collaborator OTHER

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Martin H Teicher, MD, PhD · Mclean Hospital

Eligibility

Min Age
14 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2022-12-31
Completion
2023-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05209217 on ClinicalTrials.gov