Trial Outcomes & Findings for Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania (NCT NCT00393978)

NCT ID: NCT00393978

Last Updated: 2017-09-26

Results Overview

Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 75 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2017-09-26

Participant Flow

Participant milestones

Measure	Quitiapine + Placebo Quetiapine + Placebo quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).	Quetiapine + Topiramate Quetiapine + Topiramate Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
Overall Study STARTED	37	38
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	16	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania

Baseline characteristics by cohort

Measure	Quitiapine + Placebo n=37 Participants Quetiapine + Placebo quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).	Quetiapine + Topiramate n=38 Participants Quetiapine + Topiramate Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	17.1 years STANDARD_DEVIATION 2.1 • n=5 Participants	17.7 years STANDARD_DEVIATION 2.1 • n=7 Participants	17.4 years STANDARD_DEVIATION 0.2 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.

Outcome measures

Measure	Quitiapine and Placebo n=37 Participants Quetiapine and Placebo Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).	Quetiapine and Topiramate n=38 Participants Quetiapine and Topiramate Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
Change in Joints Per Week	-10.1 joints Standard Deviation 27.2	-10.7 joints Standard Deviation 18.4

PRIMARY outcome

Timeframe: 16 weeks

Change in percent days of cannabis use per week from baseline to week 16.

Outcome measures

Measure	Quitiapine and Placebo n=37 Participants Quetiapine and Placebo Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).	Quetiapine and Topiramate n=38 Participants Quetiapine and Topiramate Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
Change in Percent Days of Cannabis Use Per Week	-29.9 cannabis use Standard Deviation 41.1	-43.5 cannabis use Standard Deviation 38.1

Adverse Events

Quitiapine + Placebo

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Quetiapine + Topiramate

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Quitiapine + Placebo n=37 participants at risk Quetiapine + Placebo quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).	Quetiapine + Topiramate n=38 participants at risk Quetiapine + Topiramate Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
Reproductive system and breast disorders Pregnancy	2.7% 1/37 • Over a period of 3 years	0.00% 0/38 • Over a period of 3 years
Psychiatric disorders Hospitalization	13.5% 5/37 • Over a period of 3 years	10.5% 4/38 • Over a period of 3 years
Psychiatric disorders Increased Suicidal Ideation	0.00% 0/37 • Over a period of 3 years	2.6% 1/38 • Over a period of 3 years

Other adverse events

Measure	Quitiapine + Placebo n=37 participants at risk Quetiapine + Placebo quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).	Quetiapine + Topiramate n=38 participants at risk Quetiapine + Topiramate Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
General disorders Difficulty falling asleep	54.1% 20/37 • Over a period of 3 years	31.6% 12/38 • Over a period of 3 years
General disorders Difficulty staying asleep	54.1% 20/37 • Over a period of 3 years	31.6% 12/38 • Over a period of 3 years
General disorders Excitement	0.00% 0/37 • Over a period of 3 years	13.2% 5/38 • Over a period of 3 years
General disorders Dry Mouth	81.1% 30/37 • Over a period of 3 years	60.5% 23/38 • Over a period of 3 years

Additional Information

Melissa P. DelBello, MD

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Phone: 513-558-2989

Email: Melissa.DelBello@uc.edu

Results disclosure agreements

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