Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Schizophrenia Schizoaffective Disorder Bipolar Disorder
Interventions:	Drug: Sublingual orally disintegrating olanzapine (SODO) Drug: Oral olanzapine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
SODO	Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
SOT	Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks

Participant Flow: Overall Study

	SODO	SOT
STARTED	84	65
COMPLETED	65	50
NOT COMPLETED	19	15
Adverse Event	2	2
Withdrawal by Subject	5	6
Lost to Follow-up	5	2
Protocol entry criteria not met	2	2
Physician Decision	2	1
Noncompliance	2	2
Protocol Violation	1	0

Baseline Characteristics

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Reporting Groups

	Description
SODO	Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
SOT	Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks

Baseline Measures

	SODO	SOT	Total
Number of Participants [units: participants]	84	65	149
Age [units: years] Mean ± Standard Deviation	38.6 ± 13.13	38.7 ± 12.23	38.6 ± 12.7
Gender [units: participants]
Female	36	32	68
Male	48	33	81
Region of Enrollment [units: participants]
United States	23	18	41
Mexico	27	23	50
Canada	29	21	50
Netherlands	5	3	8
Presence of Metabolic Syndrome [units: participants]
No	64	49	113
Yes	18	16	34
Unknown	2	0	2
Psychiatric Illness [units: participants]
Schizophrenia	46	36	82
Schizophreniform	7	2	9
Schizoaffective disorder	3	12	15
Other related psychiatric disorder	1	1	2
Bipolar disorder	27	14	41
Race/Ethnicity [units: participants]
African Descent	11	4	15
Caucasian	42	36	78
East/Southeast Asian	2	1	3
First Nations	2	0	2
Hispanic	27	23	50
Other	0	1	1
Blood Pressure [units: mm Hg] Mean ± Standard Deviation
Systolic Blood Pressure	120.3 ± 16.45	119.0 ± 12.49	119.7 ± 14.82
Diastolic Blood Pressure	77.6 ± 9.62	75.8 ± 9.15	76.8 ± 9.43
Body Mass Index [units: kilograms/meters-squared] Mean ± Standard Deviation	28.0 ± 5.63	28.3 ± 4.76	28.1 ± 5.26
Clinical Global Impression-Severity Scale ^[1] [units: units on a scale] Mean ± Standard Deviation	3.0 ± 0.78	3.2 ± 0.85	3.1 ± 0.81
Fasting Glucose [units: millimole/Liter] Mean ± Standard Deviation	5.1 ± 0.77	5.0 ± 0.46	5.1 ± 0.65
Fasting Insulin [units: micro International Unit/milliliter] Mean ± Standard Deviation	13.5 ± 14.65	10.0 ± 7.18	11.9 ± 12.06
Fasting Lipoproteins [units: millimole/Liter] Mean ± Standard Deviation
Total Cholesterol	5.1 ± 1.01	5.1 ± 1.01	5.1 ± 1.0
High-Density Lipoprotein Cholesterol	1.2 ± 0.40	1.3 ± 0.34	1.3 ± 0.37
Low-Density Lipoprotein Cholesterol	3.1 ± 0.81	3.0 ± 0.88	3.1 ± 0.84
Triglycerides	1.7 ± 0.77	1.7 ± 0.90	1.7 ± 0.83
Global Assessment of Functioning Scale ^[2] [units: units on a scale] Mean ± Standard Deviation	63.4 ± 12.82	62.5 ± 12.39	63.0 ± 12.60
Glycosylated Hemoglobin [units: percent] Mean ± Standard Deviation	5.5 ± 0.45	5.5 ± 0.38	5.5 ± 0.42
Height [units: centimeters] Mean ± Standard Deviation	170.0 ± 10.18	168.9 ± 10.23	169.5 ± 10.18
Subjective Appetite (Visual Analog Scale) ^[3] [units: units on a scale] Mean ± Standard Deviation	62.5 ± 20.85	65.7 ± 19.24	63.9 ± 20.16
Subjective Well-Being Under Neuroleptic Treatment - Short Form ^[4] [units: units on a scale] Mean ± Standard Deviation
Total Score	85.5 ± 15.59	85.6 ± 15.00	85.5 ± 15.28
Social Integration Subscale	17.0 ± 4.38	17.0 ± 3.97	17.0 ± 4.19
Physical Functioning Subscale	17.0 ± 3.53	17.2 ± 3.26	17.1 ± 3.41
Mental Functioning Subscale	16.7 ± 4.02	16.7 ± 4.20	16.7 ± 4.09
Self-Control Subscale	17.0 ± 3.45	17.3 ± 4.15	17.1 ± 3.76
Emotional Regulation Subscale	17.6 ± 4.07	17.4 ± 3.82	17.5 ± 3.95
Waist Circumference [units: centimeters] Mean ± Standard Deviation	96.1 ± 13.24	97.2 ± 12.97	96.6 ± 13.09
Weight [units: kilograms] Mean ± Standard Deviation	81.1 ± 18.97	81.2 ± 17.05	81.1 ± 18.10

[1]	Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
[2]	Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).
[3]	Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.
[4]	Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 4 to 24. Total score ranges from 20 to 120.

Outcome Measures

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1. Primary:

Time Course of Change From Baseline in Body Mass Index (BMI) [ Time Frame: Visit 2 (Baseline) to Visit 7 (16 Weeks) ]

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2. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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3. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers [ Time Frame: Visit 2 (Baseline) and Visit 7 (16 Weeks) ]

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4. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Weight [ Time Frame: Visit 2 (Baseline) and Visit 7 (16 Weeks) ]

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5. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Waist Circumference [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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6. Secondary:

Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period [ Time Frame: Visit 2 (Baseline) to Visit 7 (Week 16) ]

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7. Secondary:

Number of Participants Discontinuing the Trial by Visit (Week) [ Time Frame: Visit 2 (Baseline) to Visit 7 (Week 16) ]

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8. Secondary:

Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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9. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Blood Pressure [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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10. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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11. Secondary:

Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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12. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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13. Secondary:

Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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14. Secondary:

Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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15. Secondary:

Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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16. Secondary:

Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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17. Secondary:

Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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18. Secondary:

Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00303602 History of Changes
Other Study ID Numbers:	10268, F1D-CA-S063
Study First Received:	March 15, 2006
Results First Received:	December 19, 2008
Last Updated:	June 5, 2009
Health Authority:	United States: Food and Drug Administration