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Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00259272
First received: November 28, 2005
Last updated: April 30, 2009
Last verified: April 2009
History of Changes
Results First Received: April 30, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Disorder I or II
Intervention: Drug: olanzapine

  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
All participants received olanzapine and were grouped according to their most recent type of episode.

Reporting Groups
  Description
Manic Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
Hypomanic Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
Mixed Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
Depressive Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).

Participant Flow:   Overall Study
    Manic Episode     Hypomanic Episode     Mixed Episode     Depressive Episode  
STARTED     36     31     26     48  
COMPLETED     21     24     21     27  
NOT COMPLETED     15     7     5     21  
Adverse Event                 2                 1                 0                 3  
Lack of Efficacy                 5                 1                 2                 6  
Physician Decision                 1                 2                 1                 3  
Protocol Violation                 2                 0                 0                 1  
Sponsor Decision                 0                 1                 0                 0  
Withdrawal by Subject                 4                 2                 2                 7  
Lost to Follow-up                 1                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Manic Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
Hypomanic Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
Mixed Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
Depressive Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Total Total of all reporting groups

Baseline Measures
    Manic Episode     Hypomanic Episode     Mixed Episode     Depressive Episode     Total  
Number of Participants  
[units: participants]
 		  36     31     26     48     141  
Age  
[units: years]
Mean ± Standard Deviation 		  46.39  ± 15.32     45.81  ± 11.68     46.62  ± 12.87     44.35  ± 11.98     45.61  ± 12.91  
Gender  
[units: participants]
 		         
Female     19     21     15     25     80  
Male     17     10     11     23     61  
Region of Enrollment  
[units: participants]
 		         
France     36     31     26     48     141  
Diagnostic Summary  
[units: participants]
 		         
Bipolar Disorder I     36     14     26     31     107  
Bipolar Disorder II - Hypomanic     0     17     1     0     18  
Bipolar Disorder II - Depressed     0     0     1     17     18  
Number of Lifetime Suicide Attempts  
[units: participants]
 		         
Missing Data     2     3     1     2     8  
0     24     23     15     28     90  
1     8     3     6     5     22  
2     2     0     3     8     13  
4     0     1     0     2     3  
5     0     0     0     2     2  
6     0     1     0     0     1  
10     0     0     1     1     2  
Participants with at Least One Episode of Depression [1]
[units: participants]
 		         
Missing Data     0     0     1     0     1  
No     6     2     4     0     12  
Yes     30     29     21     48     128  
Participants with at Least One Episode of Hypomania [1]
[units: participants]
 		         
Missing Data     2     0     3     1     6  
No     30     1     14     25     70  
Yes     4     30     9     22     65  
Participants with at Least One Episode of Mania [1]
[units: participants]
 		         
Missing Data     0     3     1     0     4  
No     0     14     11     23     48  
Yes     36     14     14     25     89  
Participants with at Least One Episode of Mixed Episode [1]
[units: participants]
 		         
Missing Data     1     3     1     2     7  
No     27     25     3     32     87  
Yes     8     3     22     14     47  
Patient Status  
[units: participants]
 		         
Inpatient     26     12     10     24     72  
Outpatient     10     19     16     24     69  
Previous Central Nervous System Treatment  
[units: participants]
 		         
Yes     34     30     26     46     136  
No     2     1     0     2     5  
Suicide Ideation [2]
[units: participants]
 		         
0: Absent     35     29     15     26     105  
1: Feels Life Not Worth Living     0     2     8     12     22  
2:Wishes He Were Dead or Thoughts of Death to Self     1     0     3     10     14  
3: Suicide Ideas or Gestures     0     0     0     0     0  
4: Attempts Suicide     0     0     0     0     0  
Thymic Reactivity - Investigator-Based Assessment [3]
[units: participants]
 		         
Neither     1     2     4     3     10  
Thymic Hyper-Reactivity     34     28     20     19     101  
Thymic Hypo-Reactivity     1     1     2     26     30  
Age at Time of Onset of First Episode  
[units: years]
Mean ± Standard Deviation 		  30.57  ± 13.94     34.00  ± 13.75     27.36  ± 10.78     29.19  ± 10.41     30.29  ± 12.31  
Body Mass Index [4]
[units: kilogram per meter squared]
Mean ± Standard Deviation 		  24.80  ± 4.53     24.73  ± 4.98     26.86  ± 7.75     24.54  ± 3.70     25.09  ± 5.18  
Duration of Current Episode  
[units: months]
Mean ± Standard Deviation 		  0.99  ± 1.51     1.95  ± 3.22     1.71  ± 1.56     1.51  ± 1.49     1.53  ± 2.03  
Duration of Illness  
[units: years]
Mean ± Standard Deviation 		  16.86  ± 13.93     12.45  ± 9.52     19.28  ± 14.54     15.70  ± 11.59     15.91  ± 12.46  
Weight  
[units: kilograms]
Mean ± Standard Deviation 		  68.83  ± 12.34     69.89  ± 14.71     74.42  ± 20.00     70.85  ± 14.41     70.78  ± 15.15  
[1] Presence of at least one previous episode was defined as: number of episodes in the past 12 months reported and/or number of episodes lifetime reported and/or year of onset of the first symptoms reported.
[2] Assessed via the 17-item Hamilton Depression Rating Scale (HAMD-17) item 3. Item 3 assesses presence and level of suicidal ideations.
[3] Investigators were asked - according to your clinical experience, is the patient with: neither; thymic hyper-reactivity; or thymic hypo-reactivity.
[4] Body mass index is an estimate of body fat based on body weight divided by height squared.



  Outcome Measures
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1.  Primary:   Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score   [ Time Frame: Baseline, 6 Weeks, 24 weeks ]
  Show Outcome Measure 1

2.  Primary:   Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix   [ Time Frame: Baseline ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score   [ Time Frame: Baseline, 6 Weeks, 24 Weeks ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score   [ Time Frame: Baseline, 6 Weeks, 24 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score   [ Time Frame: Baseline, 6 Weeks, 24 Weeks ]
  Show Outcome Measure 5

6.  Secondary:   Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)   [ Time Frame: baseline and 24 weeks ]
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7.  Secondary:   Increases and Decreases in Fasting Glucose Levels   [ Time Frame: over 24 weeks ]
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8.  Secondary:   Mean Change From Baseline to 24 Week Endpoint in Lipids   [ Time Frame: Baseline and 24 Weeks ]
  Show Outcome Measure 8

9.  Secondary:   Increases and Decreases in Lipid Levels   [ Time Frame: over 24 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change From Baseline to 24 Week Endpoint in Weight   [ Time Frame: Baseline and 24 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Weight Gain Compared to Baseline   [ Time Frame: over 24 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)   [ Time Frame: 24 weeks ]
  Show Outcome Measure 12

13.  Secondary:   MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment   [ Time Frame: Baseline ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment   [ Time Frame: Baseline, 6 Weeks, 24 Weeks ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment   [ Time Frame: Baseline, 6 Weeks, 24 Weeks ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment   [ Time Frame: Baseline, 6 Weeks, 24 Weeks ]
  Show Outcome Measure 16

17.  Secondary:   Emotional Reactivity With the Physiological Measure of Heart Rate   [ Time Frame: 12 weeks ]
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18.  Secondary:   Emotional Reactivity With the Physiological Measure of Skin Conductance   [ Time Frame: 12 weeks ]
  Show Outcome Measure 18

19.  Secondary:   Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink   [ Time Frame: 12 weeks ]
  Show Outcome Measure 19

20.  Secondary:   Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink   [ Time Frame: 12 weeks ]
  Show Outcome Measure 20


  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:
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.


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
Fewer patients than planned were enrolled in the study. Not all the analyses (Principal Component Analysis, scree plot to define the structure) could be provided due to the specific formatting of the clinicaltrials.gov databank.  


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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00259272     History of Changes
Other Study ID Numbers: 9675, F1D-FP-S057
Study First Received: November 28, 2005
Results First Received: April 30, 2009
Last Updated: April 30, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)