Study in Adolescents With Schizophrenia or Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00982020
First received: September 15, 2009
Last updated: December 8, 2014
Last verified: December 2014
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bipolar I Disorder
Schizophrenia
Interventions: Drug: Olanzapine
Behavioral: Standard behavioral weight intervention
Behavioral: Intense behavioral weight intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Olanzapine/Standard Behavioral Weight Intervention Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
Olanzapine/Intense Behavioral Weight Intervention Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Participant Flow:   Overall Study
    Olanzapine/Standard Behavioral Weight Intervention     Olanzapine/Intense Behavioral Weight Intervention  
STARTED     102     101  
Received at Least 1 Dose of Study Drug     102     101  
COMPLETED     45     37  
NOT COMPLETED     57     64  
Adverse Event                 19                 15  
Withdrawal by Subject                 11                 14  
Lost to Follow-up                 5                 11  
Lack of Efficacy                 10                 4  
Parent/Caregiver Decision                 5                 5  
Treatment Non-compliance                 3                 6  
Physician Decision                 2                 5  
Entry Criteria Not Met                 2                 1  
Protocol Violation                 0                 2  
Clinical Relapse                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug

Reporting Groups
  Description
Olanzapine/Standard Behavioral Weight Intervention

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

Olanzapine/Intense Behavioral Weight Intervention

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Total Total of all reporting groups

Baseline Measures
    Olanzapine/Standard Behavioral Weight Intervention     Olanzapine/Intense Behavioral Weight Intervention     Total  
Number of Participants  
[units: participants]
  102     101     203  
Age  
[units: years]
Mean (Standard Deviation)
  15.86  (1.49)     15.66  (1.52)     15.76  (1.51)  
Gender  
[units: participants]
     
Female     50     47     97  
Male     52     54     106  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     15     9     24  
Not Hispanic or Latino     87     92     179  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     12     14     26  
White     84     80     164  
More than one race     4     5     9  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Germany     2     1     3  
Poland     6     12     18  
Russian Federation     28     27     55  
United States     53     54     107  
Puerto Rico     13     7     20  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants   [ Time Frame: Baseline, 52 weeks ]

2.  Secondary:   Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months   [ Time Frame: Baseline, 52 weeks ]

3.  Secondary:   Time to Event for 7%, 15%, and 25% Weight Gain for All Participants   [ Time Frame: Baseline up to 52 weeks ]

4.  Secondary:   Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder   [ Time Frame: Baseline, 52 weeks ]

5.  Secondary:   Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants   [ Time Frame: 52 weeks ]

6.  Secondary:   Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants   [ Time Frame: Baseline, 52 weeks ]

7.  Secondary:   Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants   [ Time Frame: Baseline, 52 weeks ]

8.  Secondary:   Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia   [ Time Frame: Baseline, 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00982020     History of Changes
Other Study ID Numbers: 12117, F1D-MC-HGMX
Study First Received: September 15, 2009
Results First Received: April 18, 2014
Last Updated: December 8, 2014
Health Authority: United States: Food and Drug Administration