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

NCT05209217 | Unknown FDA Drug

• 1 other identifier: 2017P001822
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.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

Outcome Measures

Primary Outcomes (2)

• BOLD fMRI response in amygdala

  Change in BOLD measured by functional Magnetic Resonance Imaging (fMRI) to images of threatening versus neutral facial expressions.

  Prior to and 2-3 hours following ketamine administration

• BOLD fMRI response in posterior insula

  Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and degree of cold stimulation of non-dominant hand.

  Prior to and 2-3 hours following ketamine administration

Secondary Outcomes (3)

• Functional connectivity between amygdala and insula

  Prior to and 2-3 hours following ketamine administration

• EEG spectral activity measures

  Prior to and 2-3 hours following ketamine administration

• Profile of Mood State (POMS) scale.

  Prior to and 2-3 hours following ketamine administration

Study Arms (1)

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.

Drug: Ketamine

Interventions

Ketamine DRUG

Intranasal administration of their customary prescribed dose

Participant Group

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Total sample size will be 20 subjects, with approximately equal number of males and females. Subjects recruited for the study will be between 14-40-years-of-age who meet DSM-5 criteria for Bipolar Disorder, Papolos criteria for FOH Phenotype, have been taking intranasal ketamine for at least two months

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• Juvenile Bipolar Research Foundation: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

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MeSH Terms

Conditions

Bipolar Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Martin H Teicher, MD, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Bolger, MA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Developmental Biopsychiatry Research Program

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: January 26, 2022
• Study Start: June 4, 2019
• Primary Completion: December 31, 2022
• Study Completion: January 15, 2023
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)