Recruiting

Ketamine

Sponsor:

Mclean Hospital

Code:

NCT05209217

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

Interventions

Ketamine

Study Details

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beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.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

Conditions

Bipolar Disorder

Study ID

NCT05209217

Start date

Jun 4, 2019

Status verified date

Jan, 2022

Completion date

Jan 15, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Participant Group

Participants will all have history of good to excellent clinical response to intranasal ketamine for at least two months and on a treatment schedule varying from use every other day to every fifth day. Participants will be tested one or two days beyond their customary administration date and again 2-3 hours after their administration of ketamine.

Interventions

Ketamine

Intranasal administration of their customary prescribed dose

Primary outcome measure

  • BOLD fMRI response in amygdala [ Time Frame: Prior to and 2-3 hours following ketamine administration ]
  • BOLD fMRI response in posterior insula [ Time Frame: Prior to and 2-3 hours following ketamine administration ]

Central Contacts and Locations

Central contacts

Elizabeth A Bolger, MA

617-855-2964lbolger@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Elizabeth Bolger, MA

617-855-2964lbolger@mclean.harvard.edu

Principal Investigator:

Martin H Teicher, MD, PHD

More Information

Sponsor

Mclean Hospital

Last update posted

Jan 27, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2022-01-27.