Status:
UNKNOWN
Open Study of the Neurobiological Effects of Intranasal Ketamine in Children and Adults With Bipolar Disorder
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Juvenile Bipolar Research Foundation
Conditions:
Bipolar Disorder
Eligibility:
All Genders
14-40 years
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...
Detailed Description
Clinically, the Fear of Harm phenotype is characterized by early age of onset, severe mood swings, treatment resistance, separation anxiety, fearful-aggressive obsessions, parasomnias (e.g. night-terr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 15 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05209217
Start Date
June 4 2019
End Date
January 15 2023
Last Update
January 27 2022
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478