Clinical TrialBipolar DisorderKetamineUnknown status

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

Prospective observational cohort (n=20) assessing neurobiological effects of intranasal ketamine in adolescents and adults with Bipolar Disorder — Fear of Harm phenotype; off-dose and 2–3 h post-dose neuroimaging/EEG comparisons.

Target Enrollment
20 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

Aim 1: Evaluate whether individuals with Bipolar Disorder — Fear of Harm phenotype show enhanced amygdala fMRI responses to fearful stimuli, increased resting temporal beta/gamma EEG activity, and blunted posterior insula cold responses when partially withdrawn from ketamine, with normalization after intranasal ketamine.

Aim 2: Test whether ketamine alters functional connectivity of the amygdala and insula with hypothalamus, thalamus, hippocampus and vmPFC in ways that correlate with pre–post clinical change.

Aim 3: Determine whether low-dose medicinal intranasal ketamine is associated with morphometric abnormalities seen in high-dose recreational users by scanning participants on long-term treatment.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Participant Group

experimental

Participants on a stable intranasal ketamine regimen; tested one or two days beyond their usual administration date and again 2–3 hours after dosing.

Interventions

  • Ketamine - 300 mg
    via Other• every 3-4 days

    Customary prescribed intranasal dose; will not exceed 300 mg per dosing interval; participants delay dose by 2 days for off-dose assessment

Participants

Ages
14 – 40
Sexes
Male & Female

Inclusion Criteria

  • Males and females
  • Age 14 - 40 years
  • Clinical diagnosis of Bipolar Disorder - Fear of Harm (FOH) 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 testing 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 Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2019-06-04
    End: 2023-01-15
  • Compound
    Ketamine
  • Topic
    Bipolar Disorder

Locations

McLean Hospital — Belmont, Massachusetts, United States

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