Trial Outcomes & Findings for Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes (NCT NCT00397020)

Results Overview

Minimum: 0 Maximum: 60 Higher scores indicate worse outcome

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Day 7

Results posted on

2019-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	1 Divalproex ER Divalproex ER	2 Quetiapine Fumarate quetiapine fumarate
Overall Study STARTED	14	16
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Divalproex ER n=13 Participants Divalproex ER	2 Quetiapine Fumarate n=15 Participants quetiapine fumarate	Total n=28 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	13 Participants n=5 Participants	15 Participants n=7 Participants	28 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	42.4 years n=5 Participants	36.9 years n=7 Participants	39.65 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7

Minimum: 0 Maximum: 60 Higher scores indicate worse outcome

Outcome measures

Outcome measures
Measure	1 Divalproex ER n=10 Participants Divalproex ER	2 Quetiapine Fumarate n=15 Participants quetiapine fumarate
Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7	14.8 units on a scale Standard Error 2.1	13.9 units on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: weekly - Day 3, 14, 21

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: each visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: each week/visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: each week/visit in the hospital

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: each week/visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: each week/visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: each week/visit

Outcome measures

Outcome data not reported

Adverse Events

1 Divalproex ER

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

2 Quetiapine Fumarate

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1 Divalproex ER n=13 participants at risk Divalproex ER	2 Quetiapine Fumarate n=15 participants at risk quetiapine fumarate
Nervous system disorders Neurological (fainting, dizziness, headaches)	7.7% 1/13 • Number of events 1	33.3% 5/15 • Number of events 5

Additional Information

Dr. David Feifel

UCSD Medical Center

Phone: 619-543-2485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place