Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190749
First received: September 12, 2005
Last updated: April 26, 2010
Last verified: April 2010
Results First Received: June 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: olanzapine
Drug: risperidone

  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
Study Period I was a Screening Period. Study Period II was a Inpatient Washout/Diet Stabilization Period. Study Period III (randomization) was the Double-Blind Therapy Period.

Reporting Groups
  Description
Olanzapine Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
Risperidone Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Participant Flow:   Overall Study
    Olanzapine     Risperidone  
STARTED     68     62  
COMPLETED     42     31  
NOT COMPLETED     26     31  
Lost to Follow-up                 8                 11  
Withdrawal by Subject                 10                 6  
Protocol Violation                 5                 4  
Adverse Event                 0                 5  
Lack of Efficacy                 2                 3  
Reason Not Specified                 0                 2  
Sponsor Decision                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Olanzapine Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
Risperidone Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Olanzapine     Risperidone     Total  
Number of Participants  
[units: participants]
  68     62     130  
Age  
[units: years]
Mean ± Standard Deviation
  43.49  ± 9.45     42.58  ± 8.98     43.06  ± 9.20  
Gender  
[units: participants]
     
Female     23     21     44  
Male     45     41     86  
Region of Enrollment  
[units: participants]
     
United States     68     62     130  
Diagnosis  
[units: participants]
     
Schizophrenia,paranoid     40     45     85  
Schizoaffective disorder     27     16     43  
Schizophrenia, undifferentiated     1     1     2  
Race/Ethnicity  
[units: participants]
     
Caucasian     27     30     57  
African descent     34     26     60  
Hispanic     4     5     9  
East Asian     1     0     1  
Other     2     1     3  
Brief Psychiatric Rating Scale Anxiety Depression Score-Baseline [1]
[units: units on a scale]
Mean ± Standard Deviation
  4.46  ± 2.46     3.74  ± 2.13     4.12  ± 2.33  
Brief Psychiatric Rating Scale Negative Symptom Score-Baseline [2]
[units: units on a scale]
Mean ± Standard Deviation
  2.28  ± 1.98     1.89  ± 1.79     2.09  ± 1.89  
Brief Psychiatric Rating Scale Positive Symptom Score-Baseline [3]
[units: units on a scale]
Mean ± Standard Deviation
  5.40  ± 2.69     5.47  ± 2.52     5.43  ± 2.60  
Brief Psychiatric Rating Scale Total Score-Baseline [4]
[units: units on a scale]
Mean ± Standard Deviation
  15.63  ± 6.06     14.29  ± 6.00     14.99  ± 6.04  
Clinical Global Impression Severity Score- Baseline [5]
[units: units on a scale]
Mean ± Standard Deviation
  3.68  ± 0.56     3.65  ± 0.52     3.66  ± 0.54  
Extrapyramidal Scores/Abnormal Involuntary Movement-Baseline [6]
[units: units on a scale]
Mean ± Standard Deviation
  0.42  ± 1.14     0.47  ± 1.13     0.44  ± 1.13  
Extrapyramidal Scores/Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment-Baseline [7]
[units: units on a scale]
Mean ± Standard Deviation
  0.27  ± 0.66     0.32  ± 0.67     0.29  ± 0.67  
Extrapyramidal Scores/Simpson-Angus-Baseline [8]
[units: units on a scale]
Mean ± Standard Deviation
  0.97  ± 1.87     0.90  ± 1.80     0.94  ± 1.83  
[1] Brief Psychiatric Rating Scale (BPRS) Anxiety-Depression Score assesses the degree of severity of a subject's anxiety-depression symptoms. BPRS Anxiety-Depression Score is the sum of Item Scores 1, 2, 5 and 9. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores for Anxiety-Depression range from 0 to 24.
[2] Brief Psychiatric Rating Scale (BPRS) Negative Score assesses the degree of severity of a subject's negative symptoms. BPRS Negative Score is the sum of Item Scores 3, 13, and 16. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores for Negative Score range from 0 to 18.
[3] Brief Psychiatric Rating Scale (BPRS) Positive Score assesses the degree of severity of a subject's positive symptoms. BPRS Positive Score is the sum of Item Scores 4, 11, 12, and 15. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores for Positive Score range from 0 to 24.
[4] Brief Psychiatric Rating Scale (BPRS) Total Score is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108.
[5] 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).
[6] A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.
[7] The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe).
[8] Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 itemsrated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.



  Outcome Measures
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1.  Primary:   Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate   [ Time Frame: baseline and 12 weeks ]

2.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.   [ Time Frame: 12 weeks ]

3.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)   [ Time Frame: 12 weeks ]

4.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.   [ Time Frame: 12 weeks ]

5.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.   [ Time Frame: 12 weeks ]

6.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.   [ Time Frame: 12 weeks ]

7.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.   [ Time Frame: 12 weeks ]

8.  Secondary:   Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.   [ Time Frame: 12 weeks ]

9.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.   [ Time Frame: 12 weeks ]

10.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.   [ Time Frame: 12 weeks ]

11.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.   [ Time Frame: 12 weeks ]

12.  Secondary:   Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.   [ Time Frame: 12 weeks ]

13.  Secondary:   Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.   [ Time Frame: 12 weeks ]

14.  Secondary:   Change From Baseline to 12 Week Endpoint in Body Mass Index   [ Time Frame: baseline and 12 weeks ]

15.  Secondary:   Change From Baseline to 12 Week Endpoint in Weight   [ Time Frame: baseline and 12 weeks ]

16.  Secondary:   Change From Baseline to 12 Week Endpoint in Waist Circumference   [ Time Frame: baseline and 12 weeks ]

17.  Secondary:   Change From Baseline to 12 Week Endpoint in Visceral Fat Area   [ Time Frame: baseline and 12 weeks ]

18.  Secondary:   Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area   [ Time Frame: baseline and 12 weeks ]

19.  Secondary:   Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area   [ Time Frame: baseline and 12 weeks ]

20.  Secondary:   Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores   [ Time Frame: baseline and 12 weeks ]

21.  Secondary:   Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores   [ Time Frame: baseline and 12 weeks ]

22.  Secondary:   Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores   [ Time Frame: baseline and 12 weeks ]

23.  Secondary:   Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores   [ Time Frame: baseline and 12 weeks ]

24.  Secondary:   Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores   [ Time Frame: baseline and 12 weeks ]

25.  Secondary:   Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores   [ Time Frame: baseline and 12 weeks ]

26.  Secondary:   Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol   [ Time Frame: baseline and 12 weeks ]

27.  Secondary:   Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)   [ Time Frame: baseline and 12 weeks ]

28.  Secondary:   Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)   [ Time Frame: baseline and 12 weeks ]

29.  Secondary:   Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides   [ Time Frame: baseline and 12 weeks ]

30.  Secondary:   Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses   [ Time Frame: baseline and 12 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 by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00190749     History of Changes
Other Study ID Numbers: 5296, F1D-MC-S014
Study First Received: September 12, 2005
Results First Received: June 3, 2009
Last Updated: April 26, 2010
Health Authority: United States: Food and Drug Administration