UnknownN/Aketamine

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

Sponsored by Mclean Hospital

NCT ID
NCT05209217
Target Enrollment
20 participants
Start Date
2019-06-04
Est. Completion
2023-01-15

About This Study

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beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.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

Bipolar Disorder

Interventions

  • Ketamine

Eligibility

Age:14 Years - 40 Years
Healthy Volunteers:No
View full eligibility criteria
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

Study Locations (1)

McLean Hospital
Belmont, Massachusetts, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source