Trial Outcomes & Findings for Medication, Weight Gain and GI Hormones (NCT NCT00384332)

NCT ID: NCT00384332

Last Updated: 2017-07-31

Results Overview

Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2017-07-31

Participant Flow

Participants referred by treatment providers.

Participant milestones

Measure	Arm 1- ODT Orally disintegrating olanzapine orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.	Arm 2- SOT regular olanzapine regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.
Overall Study STARTED	13	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	Arm 1- ODT Orally disintegrating olanzapine orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.	Arm 2- SOT regular olanzapine regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.
Overall Study Lost to Follow-up	4	0

Baseline Characteristics

Medication, Weight Gain and GI Hormones

Baseline characteristics by cohort

Measure	Arm 1 n=13 Participants Orally disintegrating olanzapine orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.	Arm 2 n=10 Participants regular olanzapine regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.	Total n=23 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	10 Participants n=7 Participants	23 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	36.4 years STANDARD_DEVIATION 8.5 • n=5 Participants	39.7 years STANDARD_DEVIATION 9.9 • n=7 Participants	38.05 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	10 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8

Outcome measures

Measure	Arm 1- ODT n=13 Participants Orally disintegrating olanzapine orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.	Arm 2- SOT n=10 Participants regular olanzapine regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 Baseline	76.0 kilograms Standard Error 0.6	76.1 kilograms Standard Error 0.7
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 Week 1	77.4 kilograms Standard Error 0.6	77.6 kilograms Standard Error 0.7
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 Week 4	77.8 kilograms Standard Error 0.6	78.3 kilograms Standard Error 0.7
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 Week 6	78.9 kilograms Standard Error 0.7	79.4 kilograms Standard Error 0.7
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 Week 8	79.1 kilograms Standard Error 0.7	80.1 kilograms Standard Error 0.7

SECONDARY outcome

Timeframe: 10 weeks

Population: Patients with bipolar disorder randomized to orally disintegrating versus regular olanzapine.

Montgomery Asberg Depression Rating Scale (MADRS) total score. Construct: Depression severity. Scores below represent mean change scores, endpoint minus baseline. Minimum total score: 0 (no depression). Maximum total score: 60 (severe depression). Lower (more negative) scores indicate a better outcome. There are no subscales.

Outcome measures

Measure	Arm 1- ODT n=13 Participants Orally disintegrating olanzapine orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.	Arm 2- SOT n=10 Participants regular olanzapine regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.
Change From Baseline Montgomery Asberg Depression Rating Scale	-15.5 units on a scale Standard Deviation 13.1	-15.5 units on a scale Standard Deviation 13.1

Adverse Events

Arm 1- ODT

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 2- SOT

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1- ODT n=13 participants at risk Orally disintegrating olanzapine orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.	Arm 2- SOT n=10 participants at risk regular olanzapine regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.
Gastrointestinal disorders Increased appetite	38.5% 5/13 • Number of events 5	60.0% 6/10 • Number of events 6

Additional Information

Candace Cromer

University of Alabama at Birmingham

Phone: 2059753442

Email: clreed@uab.edu

Results disclosure agreements

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