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Trial record 31 of 450 for:    QUETIAPINE

Quetiapine Treatment for Pediatric Delirium

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ClinicalTrials.gov Identifier: NCT03572257
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Rita Alvarez, Medical College of Wisconsin

Brief Summary:
This is a prospective, double-blind, randomized controlled trial to begin determining the efficacy of quetiapine as a treatment for pediatric delirium in patients admitted to the pediatric intensive care unit (PICU)

Condition or disease Intervention/treatment Phase
Delirium Drug: Quetiapine Other: Placebo Phase 2 Phase 3

Detailed Description:

Delirium is an acute syndrome with fluctuation in mental status with altered cognition and consciousness. It is a common occurrence (17% to 38%) in critically ill children with serious short-term consequences. Its pathophysiology is complex and incompletely understood. Dopaminergic, serotoninergic, glutaminergic, and cholinergic pathways in the cerebral cortex, striatum, substantia nigra, and thalamus have been implicated. Imbalance in the synthesis, release, and inactivation of neurotransmitters can result in altered cognitive function, behavior, and mood. The Society of Critical Care Medicine set the adult practice guidelines including widespread delirium screening as well as treatment to decrease duration of delirium and ameliorate its long-term effects (12). The cornerstone of pharmacologic therapy for delirium in adults is antipsychotics, both first and second-generation (13-20).

The current foundation of treatment for pediatric delirium is identifying and addressing the underlying etiology. Iatrogenic factors should be minimized, such as avoiding benzodiazepines and restraints, optimizing pain control, minimizing sedation, and treating withdrawal. The ICU environment should also be optimized to create a quiet, well-lit space with clustered care to allow for uninterrupted sleep. When non-pharmacologic treatment measures prove insufficient to manage the symptoms of delirium, we believe the second-generation antipsychotic (SGA) quetiapine may have a role in the treatment of delirium. However, there are currently no FDA-approved medications to treat delirium in this population.

The European Society of Paediatric and Neonatal Intensive Care (ESPNIC) has recently recommended that all children in the ICU be monitored for delirium but provided no guidance on recommended treatments (21), likely due to the lack of evidence of proven delirium treatment in children. An adult systematic review and meta-analysis by Kishi et al concluded that antipsychotics are superior to placebo in decreasing severity of delirium and time to response with there was no significant difference in the side effects between the two groups. Additionally, SGAs are associated with a shorter time to response and lower side effect profile than haloperidol (a first-generation antipsychotic).

A growing body of pediatric literature suggests that delirium is a serious and under recognized problem in critically ill children as well, however little research has been focused on treatment . A recent retrospective series looking at the use of quetiapine in suggested that quetiapine use for delirium treatment is a safe option in this population.

With proven efficacy in adults with delirium, an established track record in children for indications other than delirium, a favorable safety profile, and a wide therapeutic window, quetiapine is a logical choice for the next phase of research into pediatric delirium treatment. In this study are looking prospectively at the effectiveness of quetiapine as a treatment for pediatric delirium.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Double-Blind, Randomized Controlled Trial of Quetiapine as a Treatment for Delirium in Critically Ill Children
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Quetiapine (0.5 mg/kg TID x 10 days)
This study group will receive treatment with quetiapine after diagnosis of pediatric delirium. Group assignment will be blinded.
Drug: Quetiapine
Patients randomized to the study treatment group will received quetiapine at 0.5 mg/kg, three times a day for 10 days. Doses can be increased up to a maximum of 6 mg/kg/day, in increments of 0.5 mg/kg, based on the subject's clinical delirium symptoms. PRN doses of 0.5 mg/kg can be given up to three times a day based on the clinical judgement of the subject's ICU care team.

Placebo Comparator: Placebo
This study group will receive a placebo treatment after diagnosis of pediatric delirium. Group assignment will be blinded.
Other: Placebo
Patients randomized to the placebo group will be given an equivalent volume of sterile liquid or sugar pill, based on the individual subjects dosing preference or ability. Dosing will be done on the same schedule as the quetiapine group




Primary Outcome Measures :
  1. Time to resolution of delirium [ Time Frame: Screening through Study Day 14/Hospital Discharge ]
    Delirium symptoms will be monitored using CAPD (Cornell Assessment for Pediatric Delirium) score, collected twice a day. Time to resolution of delirium will be measured from the time of randomization to the time scores are within normal range (0-8). Number of days with abnormal CAPD scores will be compared between study groups



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 0 - 21 years old
  • PICU admission
  • Positive CAPD scoring

    • For developmentally normal children a CAPD score of ≥ 9
    • For developmentally delayed a CAPD score of ≥ 9 and a Richmond Agitation Sedation Scale (RASS) fluctuation of at least 2 points in the last 24 hours

Exclusion Criteria:

  • Patients under neuromuscular blockade and/or therapeutic hypothermia.
  • Patients undergoing treatment of alcohol withdrawal.
  • Patients unable to tolerate enteral medications
  • Patients on antipsychotics
  • Patients with a history of:

    • hepatic encephalopathy, hepatitis
    • elevated liver enzymes defined ALT or AST above normal range for age since hospitalization
    • baseline QTc prolongation (defined as greater than 97th percentile for age or greater than 20% increase from baseline or previous QTc)
    • major depressive disorder or bipolar disorder, and movement disorder.
  • Patients who are pregnant
  • Non-English and non-Spanish speaking subjects and/or parent/guardian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572257


Contacts
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Contact: Rita Alvarez, MD 414-266-3360 ralvarez@mcw.edu
Contact: Kate Woods, MS 414-266-5936 kawoods@mcw.edu

Locations
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United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Rita Alvarez, MD    414-266-3360    ralvarez@mcw.edu   
Contact: Kate Woods, MS    414-266-5936    kawoods@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin

Publications:

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Responsible Party: Rita Alvarez, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03572257     History of Changes
Other Study ID Numbers: 1195004
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Quetiapine Fumarate
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs