Efficacy of Quetiapine for Pediatric Delirium

NCT02056171 | Terminated Phase 1 Results DMC

• 1 other identifier: 1309014323
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.

Conditions

Delirium

Keywords

delirium; pediatrics; critical care; quetiapine

Outcome Measures

Primary Outcomes (1)

• Time to First Resolution of Delirium

  Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium \[CAPD\]). If delirium did not resolve within the 10 day period, this defaults to 10 days.

  Within the first 10 days after study enrollment

Secondary Outcomes (1)

• Total ICU Days With Delirium

  Within 10 days after study enrollment

Other Outcomes (1)

• Change in Delirium Severity

  Baseline and 3 days of study drug initiation

Study Arms (2)

Quetiapine

EXPERIMENTAL

A randomized group will receive quetiapine as treatment for delirium.

Drug: quetiapine

Placebo

PLACEBO COMPARATOR

A randomized group will receive placebo, and not quetiapine.

Other: Placebo

Interventions

quetiapine DRUG

Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.

Also known as: Seroquil

Quetiapine

Placebo OTHER

Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.

Placebo

Eligibility Criteria

• Age: 1 Year - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium

You may not qualify if:

• Age \<1
• Richmond Agitation Sedation Scale (RASS) score of -4 or -5 (deeply sedated or unarousable).
• current treatment for alcohol withdrawal
• hepatic encephalopathy
• pregnancy
• diagnosis of major depressive disorder or bipolar disorder
• diagnosis of movement disorder
• diagnosis of diabetic ketoacidosis
• baseline QTc \>500 milliseconds
• non-English speaking subjects and/or parent/guardian

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

NY Prebyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chani Traube
• Organization: Weill Cornell Medicine

chr9008@med.cornell.edu

212-746-3056

Study Officials

• Chani Traube, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-12

Locations

US (2)