Trial Outcomes & Findings for Metabolic Effects of Olanzapine in Healthy Males (NCT NCT01496183)

NCT ID: NCT01496183

Last Updated: 2018-08-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Assessed at baseline and 2 weeks
• Results posted on: 2018-08-16

Participant Flow

Participant milestones

Measure	Placebo Placebo: Placebo capsule administered orally at bedtime for 14 days	Olanzapine Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Overall Study STARTED	9	15
Overall Study COMPLETED	6	13
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Placebo Placebo: Placebo capsule administered orally at bedtime for 14 days	Olanzapine Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Overall Study Physician Decision	3	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Metabolic Effects of Olanzapine in Healthy Males

Baseline characteristics by cohort

Measure	Placebo n=6 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days	Olanzapine n=13 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.	Total n=19 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants
Age, Continuous	24.8 years STANDARD_DEVIATION 2.5 • n=5 Participants	23.1 years STANDARD_DEVIATION 5.1 • n=7 Participants	23.6 years STANDARD_DEVIATION 4.4 • n=5 Participants

PRIMARY outcome

Timeframe: Assessed at baseline and 2 weeks

Outcome measures

Measure	Placebo n=6 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=13 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline in Weight	0.2 Kg Standard Deviation 0.5	1.7 Kg Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline and 2 weeks of treatment (olanzapine or placebo)

Population: The Body Composition assessment was not implemented at the start of the study but once the study already started. Therefore, not all study participants who completed the study got the Body Composition assessment done. Only 3 participants in the Placebo Group and 6 participants in the Olanzapine Group got the Body Composition assessment done.

lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=3 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=6 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline in Body Composition lean body mass at baseline	60.1 kg Standard Deviation 0.7	65.8 kg Standard Deviation 11.3
Change From Baseline in Body Composition lean body mass at 2 weeks of treatment	60.1 kg Standard Deviation 1.7	67.0 kg Standard Deviation 11.7
Change From Baseline in Body Composition fat mass at baseline	17.9 kg Standard Deviation 11.7	16.5 kg Standard Deviation 9.4
Change From Baseline in Body Composition fat mass at 2 weeks of treatment	18.5 kg Standard Deviation 10.0	17.4 kg Standard Deviation 8.6

SECONDARY outcome

Timeframe: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=6 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=13 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline in 24-Hour Dietary Recall baseline	1748 kcal/day Standard Deviation 567	2410 kcal/day Standard Deviation 1591
Change From Baseline in 24-Hour Dietary Recall 2 weeks of treatment	1785 kcal/day Standard Deviation 562	2374 kcal/day Standard Deviation 1073

SECONDARY outcome

Timeframe: baseline and 2weeks of treatment

Resting metabolic rate at baseline and after 2 weeks of treatment

Outcome measures

Measure	Placebo n=6 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=13 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline in Resting Metabolic Rate baseline	1702 kcal/24 hours Standard Deviation 217	1855 kcal/24 hours Standard Deviation 351
Change From Baseline in Resting Metabolic Rate 2 weeks treatment	1689 kcal/24 hours Standard Deviation 309	1858 kcal/24 hours Standard Deviation 342

SECONDARY outcome

Timeframe: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.

Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=5 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=12 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline Triglycerides baseline	48.4 mg/dl Standard Deviation 13.6	93.0 mg/dl Standard Deviation 38.1
Change From Baseline Triglycerides 2 weeks of treatment	52.8 mg/dl Standard Deviation 22.1	136.6 mg/dl Standard Deviation 80.2

SECONDARY outcome

Timeframe: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.

Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=5 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=11 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline in Glucose baseline	82.4 mg/dl Standard Deviation 7.4	78.6 mg/dl Standard Deviation 8.1
Change From Baseline in Glucose 2 weeks of treatment	85.0 mg/dl Standard Deviation 4.2	82.2 mg/dl Standard Deviation 5.3

SECONDARY outcome

Timeframe: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.

Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=5 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=11 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline in Leptin baseline	3.8 ng/ml Standard Deviation 3.3	3.8 ng/ml Standard Deviation 2.7
Change From Baseline in Leptin 2 weeks treatment	4.8 ng/ml Standard Deviation 3.0	5.7 ng/ml Standard Deviation 4.3

SECONDARY outcome

Timeframe: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)

Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.

Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=5 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=11 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline in Insulin baseline	5.0 µIU/ml Standard Deviation 3.5	6.2 µIU/ml Standard Deviation 4.0
Change From Baseline in Insulin 2 weeks of treatment	5.8 µIU/ml Standard Deviation 2.7	10.1 µIU/ml Standard Deviation 7.5

SECONDARY outcome

Timeframe: baseline and 2 weeks treatment

Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.

Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=5 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=12 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Change From Baseline Total Cholesterol baseline	153.2 mg/dl Standard Deviation 23.7	156.8 mg/dl Standard Deviation 32.2
Change From Baseline Total Cholesterol 2 weeks treatment	147.4 mg/dl Standard Deviation 21.1	167.0 mg/dl Standard Deviation 42.0

SECONDARY outcome

Timeframe: baseline and 2 weeks treatment

Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.

Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=5 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=12 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
LDL baseline	88.8 mg/dl Standard Deviation 25.2	86.9 mg/dl Standard Deviation 29.2
LDL 2 weeks treatment	82.0 mg/dl Standard Deviation 12.5	93.7 mg/dl Standard Deviation 34.4

SECONDARY outcome

Timeframe: baseline and 2 weeks treatment

Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.

High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=5 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=12 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
HDL baseline	54.6 mg/dl Standard Deviation 10.2	51.3 mg/dl Standard Deviation 15.7
HDL 2 weeks treatment	55.0 mg/dl Standard Deviation 6.8	46.1 mg/dl Standard Deviation 11.2

SECONDARY outcome

Timeframe: baseline and 2 week treatment

Population: Due to poor participant's compliance with the study requirements for physical activity data collection, the data from 4 participants from the olanzapine group could not be used for analysis purpose.

Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment.

Outcome measures

Measure	Placebo n=6 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=9 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Physical Activity as Measured Using a Physical Activity Monitor baseline - weekdays	410,029 counts per day Standard Deviation 200,091	263,720 counts per day Standard Deviation 131,638
Physical Activity as Measured Using a Physical Activity Monitor 2 week treatment - weekdays	279,722 counts per day Standard Deviation 119,879	263,757 counts per day Standard Deviation 115,456
Physical Activity as Measured Using a Physical Activity Monitor baseline - weekend days	279,149 counts per day Standard Deviation 106,671	277,298 counts per day Standard Deviation 162,147
Physical Activity as Measured Using a Physical Activity Monitor 2 week treatment - weekend days	247,036 counts per day Standard Deviation 136,553	198,382 counts per day Standard Deviation 117,252

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 2 week treatment

Population: The Laboratory Breakfast Intake assessment was not performed at the start of the study but was initiated during the course of the study. Only 3 participants from the Placebo group and 6 participants from the Olanzapine group completed the Laboratory Breakfast Intake assessment.

Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo

Outcome measures

Measure	Placebo n=3 Participants Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.	Olanzapine n=6 Participants Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Laboratory Breakfast Intake Baseline	1396 kcal Standard Deviation 160	864 kcal Standard Deviation 269
Laboratory Breakfast Intake 2 week treatment	1567 kcal Standard Deviation 478	1058 kcal Standard Deviation 482

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Olanzapine

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. Elsa Daurignac, Research Assistant Professor

The State University of New York at Buffalo

Phone: 716-898-4540

Email: ecd3@buffalo.edu

Results disclosure agreements

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