Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Medication, Weight Gain and GI Hormones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00384332
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Richard C. Shelton, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Depression
Interventions Drug: orally-disintegrating olanzapine
Drug: regular olanzapine
Enrollment 20
Recruitment Details Participants referred by treatment providers.
Pre-assignment Details  
Arm/Group Title Arm 1- ODT Arm 2- SOT
Hide Arm/Group Description

Orally disintegrating olanzapine

orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.

regular olanzapine

regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.

Period Title: Overall Study
Started 13 10
Completed 9 10
Not Completed 4 0
Reason Not Completed
Lost to Follow-up             4             0
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

Orally disintegrating olanzapine

orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.

regular olanzapine

regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
10
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 10 participants 23 participants
36.4  (8.5) 39.7  (9.9) 38.05  (9.2)
[1]
Measure Description: Self-reported age.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
7
  53.8%
6
  60.0%
13
  56.5%
Male
6
  46.2%
4
  40.0%
10
  43.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 10 participants 23 participants
13 10 23
1.Primary Outcome
Title Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8
Hide Description Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1- ODT Arm 2- SOT
Hide Arm/Group Description:

Orally disintegrating olanzapine

orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.

regular olanzapine

regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.

Overall Number of Participants Analyzed 13 10
Mean (Standard Error)
Unit of Measure: kilograms
Baseline 76.0  (0.6) 76.1  (0.7)
Week 1 77.4  (0.6) 77.6  (0.7)
Week 4 77.8  (0.6) 78.3  (0.7)
Week 6 78.9  (0.7) 79.4  (0.7)
Week 8 79.1  (0.7) 80.1  (0.7)
2.Secondary Outcome
Title Change From Baseline Montgomery Asberg Depression Rating Scale
Hide Description Montgomery Asberg Depression Rating Scale (MADRS) total score. Construct: Depression severity. Scores below represent mean change scores, endpoint minus baseline. Minimum total score: 0 (no depression). Maximum total score: 60 (severe depression). Lower (more negative) scores indicate a better outcome. There are no subscales.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with bipolar disorder randomized to orally disintegrating versus regular olanzapine.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

Orally disintegrating olanzapine

orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.

regular olanzapine

regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.

Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.5  (13.1) -15.5  (13.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1- ODT Arm 2- SOT
Hide Arm/Group Description

Orally disintegrating olanzapine

orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.

regular olanzapine

regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks.

All-Cause Mortality
Arm 1- ODT Arm 2- SOT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1- ODT Arm 2- SOT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1- ODT Arm 2- SOT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/13 (38.46%)      6/10 (60.00%)    
Gastrointestinal disorders     
Increased appetite * 1 [1]  5/13 (38.46%)  5 6/10 (60.00%)  6
1
Term from vocabulary, SNOMED CT
*
Indicates events were collected by non-systematic assessment
[1]
Increased appetite
Treatment was not blinded to participants or treating physicians.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Candace Cromer
Organization: University of Alabama at Birmingham
Phone: 2059753442
EMail: clreed@uab.edu
Publications:
Layout table for additonal information
Responsible Party: Richard C. Shelton, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00384332     History of Changes
Other Study ID Numbers: 051235
First Submitted: October 4, 2006
First Posted: October 6, 2006
Results First Submitted: July 23, 2015
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017