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The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Olanzapine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weight | Assessed at baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Composition | lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo | baseline and 2 weeks of treatment (olanzapine or placebo) |
| Change From Baseline in 24-Hour Dietary Recall |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Breakfast Intake | Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo | baseline and 2 week treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L Dubovsky, M.D. | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, The State University of New York at Buffalo | Buffalo | New York | 14215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo capsule administered orally at bedtime for 14 days |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo capsule administered orally at bedtime for 14 days |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Weight | Posted | Mean | Standard Deviation | Kg | Assessed at baseline and 2 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo capsule administered orally at bedtime for 14 days |
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The small sample size, the exclusion of obese subjects, and the short olanzapine exposure in the current study may limit the interpretation and generalizability of our findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elsa Daurignac, Research Assistant Professor | The State University of New York at Buffalo | 716-898-4540 | ecd3@buffalo.edu |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Placebo capsule administered orally at bedtime for 14 days |
|
24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo |
| Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
| Change From Baseline in Resting Metabolic Rate | Resting metabolic rate at baseline and after 2 weeks of treatment | baseline and 2weeks of treatment |
| Change From Baseline Triglycerides | Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
| Change From Baseline in Glucose | Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
| Change From Baseline in Leptin | Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
| Change From Baseline in Insulin | Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
| Change From Baseline Total Cholesterol | Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo | baseline and 2 weeks treatment |
| LDL | Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo | baseline and 2 weeks treatment |
| HDL | High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo | baseline and 2 weeks treatment |
| Physical Activity as Measured Using a Physical Activity Monitor | 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. | baseline and 2 week treatment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Body Composition | lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | kg | baseline and 2 weeks of treatment (olanzapine or placebo) |
|
|
|
| Secondary | Change From Baseline in 24-Hour Dietary Recall | 24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo | Posted | Mean | Standard Deviation | kcal/day | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
|
|
|
| Secondary | Change From Baseline in Resting Metabolic Rate | Resting metabolic rate at baseline and after 2 weeks of treatment | Posted | Mean | Standard Deviation | kcal/24 hours | baseline and 2weeks of treatment |
|
|
|
| Secondary | Change From Baseline Triglycerides | Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | mg/dl | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
|
|
|
| Secondary | Change From Baseline in Glucose | Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | mg/dl | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
|
|
|
| Secondary | Change From Baseline in Leptin | Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | ng/ml | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
|
|
|
| Secondary | Change From Baseline in Insulin | Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | µIU/ml | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) |
|
|
|
| Secondary | Change From Baseline Total Cholesterol | Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | mg/dl | baseline and 2 weeks treatment |
|
|
|
| Secondary | LDL | Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | mg/dl | baseline and 2 weeks treatment |
|
|
|
| Secondary | HDL | High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | mg/dl | baseline and 2 weeks treatment |
|
|
|
| Secondary | Physical Activity as Measured Using a Physical Activity Monitor | 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. | 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. | Posted | Mean | Standard Deviation | counts per day | baseline and 2 week treatment |
|
|
|
| Other Pre-specified | Laboratory Breakfast Intake | Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo | 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. | Posted | Mean | Standard Deviation | kcal | baseline and 2 week treatment |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 13 | 0 | 13 |
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| D006571 | Heterocyclic Compounds |
| fat mass at baseline |
|
| fat mass at 2 weeks of treatment |
|
| baseline - weekend days |
|
| 2 week treatment - weekend days |
|