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Trial Outcomes & Findings for A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room (NCT NCT00457366)

NCT ID: NCT00457366

Last Updated: 2019-07-26

Results Overview

The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

72 participants

Primary outcome timeframe

Two hours

Results posted on

2019-07-26

Participant Flow

Participant milestones

Participant milestones
Measure
Quetiapine
Quetiapine is being compared to a "cocktail" consisting of haloperidol, lorazepam, and cogentin to see which works best in agitated patients that are being brought into the ER.
"Cocktail" Consisting of Haloperidol, Lorazepam, Cogentin
This "cocktail" consisting of haloperidol, lorazepam, and cogentin is being compared to quetiapiene to see which works best in agitated patients that are being brought into the ER.
Overall Study
STARTED
40
32
Overall Study
COMPLETED
40
32
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Quetiapine
n=38 Participants
Quetiapine Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD
Cocktail
n=34 Participants
Cocktail (Haloperidol, Lorazepam, Cogentin) Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary
Total
n=72 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=5 Participants
34 Participants
n=7 Participants
72 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
36.1 years
n=5 Participants
35.8 years
n=7 Participants
36.0 years
n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
6 Participants
n=7 Participants
15 Participants
n=5 Participants
Sex: Female, Male
Male
29 Participants
n=5 Participants
28 Participants
n=7 Participants
57 Participants
n=5 Participants
Region of Enrollment
United States
38 participants
n=5 Participants
34 participants
n=7 Participants
72 participants
n=5 Participants

PRIMARY outcome

Timeframe: Two hours

Population: 34 patients received the Cocktail, but 4 of these were excluded from the analysis because they had only demographic data and no clinical outcome data. A total of 38 patients received Quetiapine; all were included in the analysis.

The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).

Outcome measures

Outcome measures
Measure
Cocktail
n=30 Participants
Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary.
Quetiapine
n=38 Participants
Quetiapine 300 mg PO
Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.
-11.0 score on a scale
Standard Error 0.82
-11.5 score on a scale
Standard Error 0.69

Adverse Events

Quetiapine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cocktail

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr George Simpson

USC

Phone: 7604687106

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place