Trial record 1 of 12 for:    ketamine bipolar disorder
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Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder (IKBP)

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Juvenile Bipolar Research Foundation
ClinicalTrials.gov Identifier:
NCT01504659
First received: January 3, 2012
Last updated: November 20, 2013
Last verified: November 2013

January 3, 2012
November 20, 2013
July 2012
December 2013   (final data collection date for primary outcome measure)
  • Young Mania Rating Scale [ Time Frame: Change from baseline at 8 days ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale [ Time Frame: Change from baseline at 11 days ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale [ Time Frame: Change from baseline at 14 days ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale [ Time Frame: Change from baseline at 17 days ] [ Designated as safety issue: No ]
  • Overt Aggression Scale [ Time Frame: Change from baseline at day 8 ] [ Designated as safety issue: No ]
  • Overt Aggression Scale [ Time Frame: Change from baseline at day 11 ] [ Designated as safety issue: No ]
  • Overt Aggression Scale [ Time Frame: Change from baseline at day 14 ] [ Designated as safety issue: No ]
  • Overt Aggression Scale [ Time Frame: Change from baseline at day 17 ] [ Designated as safety issue: No ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: Change from baseline at Day 18, aggressive and obsessive questions ] [ Designated as safety issue: No ]
  • Change from baseline in Young Mania Rating Scale [ Time Frame: Change from baseline at 8 days ] [ Designated as safety issue: No ]
  • Change from baseline in Young Mania Rating Scale [ Time Frame: Change from baseline at 11 days ] [ Designated as safety issue: No ]
  • Change from baseline in Young Mania Rating Scale [ Time Frame: Change from baseline at 14 days ] [ Designated as safety issue: No ]
  • Change from baseline in Young Mania Rating Scale [ Time Frame: Change from baseline at 17 days ] [ Designated as safety issue: No ]
  • Change from baseline in Overt Aggression Scale [ Time Frame: Change from baseline at day 8 ] [ Designated as safety issue: No ]
  • Change from baseline in Overt Aggression Scale [ Time Frame: Change from baseline at day 11 ] [ Designated as safety issue: No ]
  • Change from baseline in Overt Aggression Scale [ Time Frame: Change from baseline at day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in Overt Aggression Scale [ Time Frame: Change from baseline at day 17 ] [ Designated as safety issue: No ]
  • Change from baseline in aggressive/obsessive questions of Yale Brown Obsessive Compulsive Scale [ Time Frame: Change from baseline at day 17 ] [ Designated as safety issue: No ]
  • Change from baseline in aggressive/obsessive questions of Yale Brown Obsessive Compulsive Scale [ Time Frame: Change from baseline at day 8 ] [ Designated as safety issue: No ]
  • Change from baseline in aggressive/obsessive questions of Yale Brown Obsessive Compulsive Scale [ Time Frame: Change from baseline at day 11 ] [ Designated as safety issue: No ]
  • Change from baseline in obsessive/aggressive questions of Yale Brown Obsessive Compulsive Scale [ Time Frame: Change from baseline at day 14 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01504659 on ClinicalTrials.gov Archive Site
  • Wechsler Intelligence Scale for Children-IV [ Time Frame: Change from baseline at day 18 ] [ Designated as safety issue: No ]
  • Peripheral Thermal Challenge [ Time Frame: Change from baseline on days 6, 7, 15 and 16 ] [ Designated as safety issue: No ]
  • body temperature [ Time Frame: Change from baseline over 16 hours spanning days 6-7 and 15-16. ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure skin and tympanic temperature using conventional thermistors and IR sensors
  • Triaxial acceleration [ Time Frame: Change from baseline over 16 hours spanning days 6-7 and 15-16. ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
  • SpO2 [ Time Frame: Change from baseline over 16 hours spanning days 6-7 and 15-16. ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
  • Galvanic skin response [ Time Frame: Change from baseline over 16 hours spanning days 6-7 and 15-16. ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure galvanic skin response obtained with two conventional electrodes.
  • Delis-Kaplin Executive Function System [ Time Frame: Change from baseline on day 18 ] [ Designated as safety issue: No ]
  • Conner's Continuous Performance Test [ Time Frame: Change from baseline on day 18 ] [ Designated as safety issue: No ]
  • SCARED [ Time Frame: change from baseline at day 18 ] [ Designated as safety issue: No ]
  • Change from baseline on the Wechsler Intelligence Scale for Children-IV [ Time Frame: Change from baseline at day 16 ] [ Designated as safety issue: No ]
  • Change from baseline on the Peripheral Thermal Challenge [ Time Frame: Change from baseline at day 9 ] [ Designated as safety issue: No ]
  • Change from baseline of body temperature [ Time Frame: Change from baseline over 48 hours spanning days 15-17 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure skin and tympanic using conventional thermistors and IR sensors
  • Change from baseline in EEG [ Time Frame: Change from baseline over 24 hours spanning days 6 and 7 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure EEG via conventional electrodes.
  • Change from baseline in EEG [ Time Frame: Change from baseline over 48 hours spanning days 15-17 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure EEG via conventional electrodes.
  • Change from baseline in triaxial acceleration [ Time Frame: Change from baseline over 24 hours spanning days 5 and 6 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
  • Change from baseline of triaxial acceleration [ Time Frame: Change from baseline over 48 hours spanning days 15-17 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
  • Change from baseline of SpO2 [ Time Frame: Change from baseline over 24 hours spanning days 5 and 6 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
  • Change from baseline of SpO2 [ Time Frame: Change from baseline over 48 hours spanning days 15-17 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
  • Change from baseline in galvanic skin response [ Time Frame: Change from baseline over 24 hours spanning days 5 and 6 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure galvanic skin response obtained with two conventional electrodes.
  • Change from baseline of galvanic skin response [ Time Frame: Change from baseline over 48 hours spanning days 15-17 of the study ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure galvanic skin response obtained with two conventional electrodes.
  • Change from baseline in body temperature [ Time Frame: Change from baseline over 24 hours spanning days 5 and 6 of the study. ] [ Designated as safety issue: No ]
    A proprietary ambulatory monitor will measure skin and tympanic using conventional thermistors and IR sensors
  • Change from baseline on Delis-Kaplin Executive Function System [ Time Frame: Change from baseline on day 16 ] [ Designated as safety issue: No ]
  • Change from baseline on Conner's Continuous Performance Test [ Time Frame: Change from baseline on day 16 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder

The investigators plan to evaluate the efficacy and safety of intranasal Ketalar (ketamine hydrochloride) in the treatment of primary symptom manifestations of pediatric bipolar disorder; Fear of Harm (FOH) phenotype. This phenotype represents those children who are most resistant to traditional treatments and suffer repeated hospitalizations. Primary symptoms include fearfulness, aggression secondary to threat, mood and/or arousal instability, and psychosis. In addition to evaluation of efficacy and safety, the investigators will also analyze whether therapeutic response depends upon the degree to which the subject fits the FOH phenotype.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Ketamine hydrochloride injection
    Separate dosing regimens will be applied depending on the weight of the child. Group A with minimum-maximum weight of 20 kg-40 kg will receive a fixed initial dose of 10 mg ketamine(0.25-0.5mg/kg)and will not exceed a maximum dose of 40 mg ketamine. Group B with minimum - maximum weight of 40.01kg-100kg will get a fixed initial dose of 20 mg ketamine(0.20-0.5mg/kg) and will not exceed a maximum dose of 120mg. ketamine. There will be 4 administrations of the drug at three day intervals. Titration upward will depend upon degree of side effects, improvement from baseline on primary measures, subjective opinion. Doses will be held constant as long as a therapuetic response, as measure of 80% improvement on YBOCS and YMRS, is reached.
    Other Names:
    • Ketalar NDA 016812
    • Ketamine Hydrochloride Injection, Abbot Hospital, 074549
    • Ketamine Hdyrochloride Injection, Bioniche, 076092
    • Ketamine Hydrochloride Injection, Bedford, 074524
    • Calypsol
    • Ketalin
    • Ketamax
    • Ketanest
    • Ketava
    • Ketmin
    • Ketolar
    • Petar
    • Soon-Soon
  • Drug: Flat tonic water (e.g., Canada Dry Tonic Water)
    Separate dosing regimens will be applied depending on the weight of the child. Group A with minimum-maximum weight of 20 kg-40 kg will receive a fixed initial dose of 0.1cc placebo and not exceed a maximum dose of 0.4cc placebo. Group B with minimum - maximum weight of 40.01kg-100kg will get a fixed initial dose of 0.2cc placebo and will not exceed a maximum dose of 1.2cc. placebo. There will be 4 administrations of the placebo at three day intervals. Titration upward will depend upon degree of side effects, improvement from baseline on primary measures, and subjective opinion. Doses will be held constant as long as a therapuetic response, as a measure of 80% improvement on YBOCS and YMRS, is reached.
  • Active Comparator: Bipolar-Ketalar
    Children with a diagnosis of BP-I, BP-II or BP-NOS will receive 4 administrations of intranasal ketalar
    Intervention: Drug: Ketamine hydrochloride injection
  • Placebo Comparator: Bipolar-Placebo
    Children with a diagnosis of BP-I, BP-II or BP-NOS will receive 4 administrations of placebo
    Intervention: Drug: Flat tonic water (e.g., Canada Dry Tonic Water)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01504659
JBRF001
Yes
Juvenile Bipolar Research Foundation
Juvenile Bipolar Research Foundation
Not Provided
Principal Investigator: Demitri Papolos, MD Juvenile Bipolar Research Foundation
Juvenile Bipolar Research Foundation
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP