Trial Outcomes & Findings for Seroquel for Frequent, Heavy Drinkers (NCT NCT00674765)

NCT ID: NCT00674765

Last Updated: 2014-09-17

Results Overview

The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 156 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-09-17

Participant Flow

Participant milestones

Measure	Seroquel Seroquel Seroquel: 400 mg/day	Placebo Placebo Placebo: 400 mg/day
Overall Study STARTED	81	75
Overall Study COMPLETED	45	46
Overall Study NOT COMPLETED	36	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seroquel for Frequent, Heavy Drinkers

Baseline characteristics by cohort

Measure	Seroquel n=81 Participants Seroquel Seroquel: 400 mg/day	Placebo n=75 Participants Placebo Placebo: 400 mg/day	Total n=156 Participants Total of all reporting groups
Age, Continuous	43.0 years STANDARD_DEVIATION 9.9 • n=5 Participants	45.4 years STANDARD_DEVIATION 11.3 • n=7 Participants	44.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
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	81 Participants n=5 Participants	75 Participants n=7 Participants	156 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	60 Participants n=7 Participants	125 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants	75 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.

Outcome measures

Measure	Seroquel (Quetiapine) n=81 Participants Seroquel (quetiapine) Seroquel: 400 mg/day	Placebo Sugar Pill n=75 Participants Placebo Placebo: 400 mg/day
TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase	20 percent days of heavy drinking	24 percent days of heavy drinking

Adverse Events

Seroquel

Serious events: 0 serious events

Other events: 76 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Seroquel n=81 participants at risk Seroquel Seroquel: 400 mg/day	Placebo n=75 participants at risk Placebo Placebo: 400 mg/day
General disorders Sedation	53.1% 43/81	29.3% 22/75
General disorders Dry Mouth	19.8% 16/81	8.0% 6/75
Metabolism and nutrition disorders Increased appetite	16.0% 13/81	8.0% 6/75
General disorders Headache	4.9% 4/81	9.3% 7/75

Additional Information

Dr. Kyle Kampman

University of Pennsylvania

Phone: 215-222-3200

Email: kampman@mail.med.upenn.edu

Results disclosure agreements

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