Trial Outcomes & Findings for A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers (NCT NCT00741026)

NCT ID: NCT00741026

Last Updated: 2014-07-14

Results Overview

Leptin following placebo or olanzapine treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 3 Days
• Results posted on: 2014-07-14

Participant Flow

A total of 42 individuals were screened between July 2008 and June 2009, and of those individuals 15 subjects were eligible based on inclusion/exclusion criteria.

Only individuals that met inclusion/exclusion criteria were allowed to participate in the study. Of the 42 individuals screened, only 15 met criteria and were interested in taking part in the study. There was a minimum 2 week washout period in between treatment arms (i.e. placebo vs active compound).

Participant milestones

Measure	Placebo / Olanzapine Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights. OR Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days. Randomization information not available.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers

Baseline characteristics by cohort

Measure	Placebo / Olanzapine n=15 Participants Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights. OR Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.6 years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Days

Leptin following placebo or olanzapine treatment

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Plasma Leptin	6.8 ng/ml Standard Deviation 1.3	8.4 ng/ml Standard Deviation 1.7

PRIMARY outcome

Timeframe: 3 Days

Oral Glucose Tolerance

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Oral Glucose Tolerance	2808 min*mg/dl Standard Deviation 474	3984 min*mg/dl Standard Deviation 444

PRIMARY outcome

Timeframe: 3 Days

Plasma Free Fatty Acid

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Plasma Free Fatty Acid	0.38 mM Standard Deviation 0.06	0.26 mM Standard Deviation 0.04

SECONDARY outcome

Timeframe: 3 Days

HDL Cholesterol

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
HDL Cholesterol	54.2 mg/dl Standard Deviation 4.7	48.9 mg/dl Standard Deviation 4.3

SECONDARY outcome

Timeframe: 3 Days

Triglycerides

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Triglycerides	88.9 mg/dl Standard Deviation 10.1	108.2 mg/dl Standard Deviation 11.6

SECONDARY outcome

Timeframe: 3 Days

LDL Cholesterol

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
LDL Cholesterol	82.7 mg/dl Standard Deviation 6.6	81.7 mg/dl Standard Deviation 7.8

SECONDARY outcome

Timeframe: 3 Days

Total Cholesterol

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Total Cholesterol	156.8 mg/dl Standard Deviation 9.1	152.6 mg/dl Standard Deviation 10.1

SECONDARY outcome

Timeframe: 3 Days

Body Weight

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Body Weight	68.2 kg Standard Error 2.9	68.9 kg Standard Error 3.0

SECONDARY outcome

Timeframe: 3 Days

BMI

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
BMI	23.0 kg / m2 Standard Error 0.5	23.0 kg / m2 Standard Error 0.6

SECONDARY outcome

Timeframe: 3 Days

Heart Rate

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Heart Rate	69.9 beats per minute Standard Error 2.6	67.6 beats per minute Standard Error 3.5

SECONDARY outcome

Timeframe: 3 Days

Systolic Blood Pressure

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Systolic Blood Pressure	113.3 mmHg Standard Error 2.8	111.7 mmHg Standard Error 3.1

SECONDARY outcome

Timeframe: 3 Days

Diastolic Blood Pressure

Outcome measures

Measure	Placebo n=15 Participants	Olanzapine n=15 Participants
Diastolic Blood Pressure	68.3 mmHg Standard Error 2.0	69.5 mmHg Standard Error 1.8

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

Vance L. Albaugh, Principle Investigator

American Medical Association

Phone: (800) 243-1455

Email: vance.l.albaugh@vanderbilt.edu

Results disclosure agreements

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