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| Name | Class |
|---|---|
| American Medical Association | OTHER |
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The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Olanzapine | Experimental | Olanzapine 10mg po daily x 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine 10 mg po qhs for 3 days | Drug | (1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Leptin | Leptin following placebo or olanzapine treatment | 3 Days |
| Oral Glucose Tolerance | Oral Glucose Tolerance | 3 Days |
| Plasma Free Fatty Acid | Plasma Free Fatty Acid | 3 Days |
| Measure | Description | Time Frame |
|---|---|---|
| HDL Cholesterol | HDL Cholesterol | 3 Days |
| Triglycerides | Triglycerides | 3 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Singareddy, M.D. | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Study Director |
| Vance L Albaugh, M.D., Ph.D. | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16493121 | Background | Albaugh VL, Henry CR, Bello NT, Hajnal A, Lynch SL, Halle B, Lynch CJ. Hormonal and metabolic effects of olanzapine and clozapine related to body weight in rodents. Obesity (Silver Spring). 2006 Jan;14(1):36-51. doi: 10.1038/oby.2006.6. | |
| 20308992 | Background | Albaugh VL, Judson JG, She P, Lang CH, Maresca KP, Joyal JL, Lynch CJ. Olanzapine promotes fat accumulation in male rats by decreasing physical activity, repartitioning energy and increasing adipose tissue lipogenesis while impairing lipolysis. Mol Psychiatry. 2011 May;16(5):569-81. doi: 10.1038/mp.2010.33. Epub 2010 Mar 23. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Plasma Leptin | Leptin following placebo or olanzapine treatment | Posted | Mean | Standard Deviation | ng/ml | 3 Days |
|
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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 : (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets) |
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One episode of orthostatic hypotension requiring unblinding. One individual with emesis after glucose challenge and that individual's glucose tolerance data were unavailable analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vance L. Albaugh, Principle Investigator | American Medical Association | (800) 243-1455 | vance.l.albaugh@vanderbilt.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Placebo | Drug | (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets) |
|
|
| LDL Cholesterol | LDL Cholesterol | 3 Days |
| Total Cholesterol | Total Cholesterol | 3 Days |
| Body Weight | Body Weight | 3 Days |
| BMI | BMI | 3 Days |
| Heart Rate | Heart Rate | 3 Days |
| Systolic Blood Pressure | Systolic Blood Pressure | 3 Days |
| Diastolic Blood Pressure | Diastolic Blood Pressure | 3 Days |
| 20494946 | Background | Albaugh VL, Vary TC, Ilkayeva O, Wenner BR, Maresca KP, Joyal JL, Breazeale S, Elich TD, Lang CH, Lynch CJ. Atypical antipsychotics rapidly and inappropriately switch peripheral fuel utilization to lipids, impairing metabolic flexibility in rodents. Schizophr Bull. 2012 Jan;38(1):153-66. doi: 10.1093/schbul/sbq053. Epub 2010 May 21. |
| 21857944 | Result | Albaugh VL, Singareddy R, Mauger D, Lynch CJ. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers. PLoS One. 2011;6(8):e22662. doi: 10.1371/journal.pone.0022662. Epub 2011 Aug 9. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Oral Glucose Tolerance | Oral Glucose Tolerance | Posted | Mean | Standard Deviation | min*mg/dl | 3 Days |
|
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| Primary | Plasma Free Fatty Acid | Plasma Free Fatty Acid | Posted | Mean | Standard Deviation | mM | 3 Days |
|
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|
|
| Secondary | HDL Cholesterol | HDL Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 3 Days |
|
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| Secondary | Triglycerides | Triglycerides | Posted | Mean | Standard Deviation | mg/dl | 3 Days |
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| Secondary | LDL Cholesterol | LDL Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 3 Days |
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| Secondary | Total Cholesterol | Total Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 3 Days |
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| Secondary | Body Weight | Body Weight | Posted | Mean | Standard Error | kg | 3 Days |
|
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| Secondary | BMI | BMI | Posted | Mean | Standard Error | kg / m2 | 3 Days |
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| Secondary | Heart Rate | Heart Rate | Posted | Mean | Standard Error | beats per minute | 3 Days |
|
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| Secondary | Systolic Blood Pressure | Systolic Blood Pressure | Posted | Mean | Standard Error | mmHg | 3 Days |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic Blood Pressure | Posted | Mean | Standard Error | mmHg | 3 Days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Olanzapine | 0 | 15 | 0 | 15 |
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| D004700 | Endocrine System Diseases |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |