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Unable to recruit subjects at our site within the past year.
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This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.
Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication.
Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine | Experimental | A randomized group will receive quetiapine as treatment for delirium. |
|
| Placebo | Placebo Comparator | A randomized group will receive placebo, and not quetiapine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine | Drug | Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total ICU Days With Delirium | Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period. | Within 10 days after study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Delirium Severity | Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores. |
Inclusion Criteria:
- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chani Traube, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| NY Prebyterian Hospital/Weill Cornell Medical Center |
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Six participants were enrolled over 22 months between March 2015 and December 2016. The first participant was enrolled in March 2015 and the last participant was enrolled in December 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine | A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine. |
| FG001 | Placebo | A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants are included in analysis. | Posted | Mean | Full Range | days | Within the first 10 days after study enrollment |
|
22 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine | A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| movement disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chani Traube | Weill Cornell Medicine | 212-746-3056 | chr9008@med.cornell.edu |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Placebo | Other | Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo. |
|
| Baseline and 3 days of study drug initiation |
| New York |
| New York |
| 10065 |
| United States |
A randomized group will receive placebo, and not quetiapine.
Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo. |
|
|
| Secondary | Total ICU Days With Delirium | Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period. | Posted | Mean | Full Range | days | Within 10 days after study enrollment |
|
|
|
| Other Pre-specified | Change in Delirium Severity | Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores. | Change in CAPD score from baseline to day 3. A decrease in total score implies an improvement in delirium. An increase in total score implies worsening delirium. | Posted | Median | Full Range | units on a scale | Baseline and 3 days of study drug initiation |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Placebo | A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo. | 0 | 3 | 1 | 3 | 0 | 3 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |