Clinical TrialBipolar DisorderKetaminePlaceboTerminated

Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder

Randomized, parallel Phase II/III study (n=5) of intranasal ketamine (Ketalar) vs placebo in children aged 6–12 with treatment‑resistant pediatric bipolar disorder (Fear of Harm phenotype); four intranasal administrations at three‑day intervals.

Target Enrollment
5 participants
Study Type
Phase II/III interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, triple‑blind, parallel trial comparing intranasal ketamine hydrochloride (Ketalar) with intranasal placebo in children aged 6–12 with DSM‑IV bipolar presentations including the Fear of Harm phenotype; four administrations given every three days.

Dosing is weight‑based with titration: Group A (20–40 kg) initial 10 mg (≈0.25–0.5 mg/kg), max 40 mg; Group B (40.01–100 kg) initial 20 mg (≈0.20–0.5 mg/kg), max 120 mg. Outcomes include safety, tolerability, and efficacy measures (YMRS, YBOCS); titration depends on side effects and improvement from baseline.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Ketalar

experimental

Intranasal ketamine hydrochloride, four administrations at three-day intervals; weight‑based dosing with titration.

Interventions

  • Ketamine10 - 120 mg
    via Other• four administrations at three day intervals• 4 doses total

    Intranasal. Group A (20–40 kg): initial 10 mg (≈0.25–0.5 mg/kg), max 40 mg. Group B (40.01–100 kg): initial 20 mg (≈0.20–0.5 mg/kg), max 120 mg. Titration based on side effects and response (up to 80% improvement criteria).

Placebo

inactive

Intranasal placebo (flat tonic water), four administrations at three-day intervals; weight‑based volumes.

Interventions

  • Placebo0.1 - 1.2 ml
    via Other• four administrations at three day intervals• 4 doses total

    Flat tonic water (e.g., Canada Dry); intranasal volumes weight-based (0.1–0.4 ml or 0.2–1.2 ml by weight group).

Participants

Ages
6 – 12
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Males and females aged 6-12;
  • 2. DSM-IV bipolar disorder (BPI, BPII, BP-NOS, BP-FOH);
  • 3. Treatment resistant - failure to adequately respond to at least 2 different classes of medications such as mood stabilizers and antipsychotic agent.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Contraindication to the use of ketamine, including allergy and current use of medicine contraindicated with ketamine;
  • 2. Endocrine or neurological illness;
  • 3. Previous history of closed head injury, current head injury associated with possible intracranial hypertension, central nervous system masses, abnormalities, or hydrocephalus, ever had loss of consciousness;
  • 4. Previous history of glaucoma or acute globe injury;
  • 5. Abnormal nasal physiology which would not allow for adequate medication delivery;
  • 6. Any change in medication type or dose within the past 30 days;
  • 7. Treatment with any MAOI's currently or within the past 3 months;
  • 8. Has had a course of ECT within the past 3 months;
  • 9. Has ever used PCP or ketamine;
  • 10. Meets DSM-IV criteria for Mental Retardation;
  • 11. Has ever had Repetitive Transcranial Magnetic Stimulation (rTMS), Vagal Nerve Stimulation (VNS) or Deep Brain Stimulation;
  • 12. Is currently hospitalized;
  • 13. Has known or suspected schizophrenia, even if currently stable or controlled with medications;
  • 14. Is acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others) including any serious attempts/those requiring hospitalization in the past 12 months or at the PI's discretion;
  • 15. The presence of any abnormal laboratory findings or serious medical disorder or condition including: clinically significant organ system dysfunction; significant endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease (myocardial ischemia, heart failure, arrhythmias); coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the SA or AV node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e.g., chronic obstructive or restrictive pulmonary disease); body weight approximately < 80% or > 120% ideal body weight; or any medical condition known to interfere with cognitive performance; medication-related exclusions include narcotic therapy, chronic acetaminophen use, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, regularly dosed narcotics or any other sedative therapy or medication that interferes with SA or AV node function or could be considered contraindicated with the sedative properties of ketamine.

Study Details

  • Status
    Terminated
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment5 participants
  • Timeline
    Start: 2012-01-07
    End: 2016-01-11
  • Compounds
    KetaminePlacebo
  • Topic
    Bipolar Disorder

Locations

Individual homes of subjects — Not Predetermined, Connecticut, United States
Juvenile Bipolar Research Foundation — Maplewood, New Jersey, United States
Individual homes of subjects — Not Predetermined, New Jersey, United States
Individual homes of subjects — Not Predetermined, New York, United States

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