A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00422162
First received: January 11, 2007
Last updated: July 22, 2011
Last verified: July 2011
Results First Received: August 25, 2009  
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
Condition: Major Depressive Disorder
Interventions: Drug: Duloxetine hydrochloride
Drug: Placebo

  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
Of the 392 patients who signed informed consent, 339 were randomized.

Reporting Groups
  Description
Duloxetine (60 mg) 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
Duloxetine (120 mg) 60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)

Participant Flow:   Overall Study
    Duloxetine (60 mg)     Duloxetine (120 mg)  
STARTED     167     172  
Received Treatment     167     171  
COMPLETED     143     142  
NOT COMPLETED     24     30  
Adverse Event                 11                 9  
Lack of Efficacy                 4                 10  
Withdrawal by Subject                 7                 6  
Lost to Follow-up                 1                 2  
Non-Compliant with Protocol                 1                 1  
Not Specified                 0                 1  
Didn't Receive Treatment                 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.
No text entered.

Reporting Groups
  Description
Duloxetine (60 mg) 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
Duloxetine (120 mg) 60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
Total Total of all reporting groups

Baseline Measures
    Duloxetine (60 mg)     Duloxetine (120 mg)     Total  
Number of Participants  
[units: participants]
  167     171     338  
Age  
[units: years]
Mean ± Standard Deviation
  45.7  ± 13.9     43.9  ± 12.7     44.8  ± 13.3  
Gender  
[units: participants]
     
Female     118     133     251  
Male     49     38     87  
Region of Enrollment  
[units: participants]
     
France     64     64     128  
South Africa     15     17     32  
Russian Federation     81     84     165  
Italy     7     6     13  
Previous Major Depressive Disorder Episodes  
[units: participants]
     
Yes     144     150     294  
No     23     21     44  
Race/Ethnicity  
[units: participants]
     
Asian     2     0     2  
Black     4     8     12  
Caucasian     161     163     324  
Age at First Major Depressive Episode  
[units: years]
Mean ± Standard Deviation
  36.3  ± 13.3     35.6  ± 12.4     36.0  ± 12.8  
Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
     
Systolic Blood Pressure     118.7  ± 12.4     119.4  ± 14.8     119.1  ± 13.7  
Diastolic Blood Pressure     74.6  ± 8.5     74.7  ± 8.2     74.7  ± 8.3  
Body Mass Index (BMI) [1]
[units: kilograms/square meter (kg/m^2)]
Mean ± Standard Deviation
  25.2  ± 5.5     25.5  ± 5.5     25.3  ± 5.5  
Duration of Previous Major Depressive Disorder (MDD) Episode [2]
[units: weeks]
Mean ± Standard Deviation
  16.4  ± 19.0     13.7  ± 11.3     15.0  ± 15.6  
Height  
[units: centimeters (cm)]
Mean ± Standard Deviation
  167.1  ± 8.1     166.5  ± 7.6     166.8  ± 7.9  
Number of Previous Hospitalizations [3]
[units: number of hospitalizations]
Mean ± Standard Deviation
  1.3  ± 1.6     1.5  ± 2.3     1.4  ± 2.0  
Number of Previous Major Depressive Disorder (MDD) Episodes [4]
[units: number of episodes]
Mean ± Standard Deviation
  3.2  ± 2.7     3.1  ± 3.0     3.2  ± 2.9  
Pulse Rate  
[units: beats per minute]
Mean ± Standard Deviation
  76.0  ± 8.8     75.8  ± 9.2     75.9  ± 9.0  
Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation
  70.4  ± 16.7     70.6  ± 15.2     70.5  ± 15.9  
[1] Body mass index is an estimate of body fat based on body weight in kilograms divided by height in meters squared.
[2] Duration of previous MDD episode in participants who experienced a previous MDD episode.
[3] Number of hospitalizations for MDD in participants who experienced previous MDD episodes.
[4] Number of previous MDD episodes for participants who experienced previous MDD episodes.



  Outcome Measures
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1.  Primary:   Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline to Week 4 ]

2.  Secondary:   Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline   [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 6, 8 ]

3.  Secondary:   Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline   [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 6, 8 ]

4.  Secondary:   Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)   [ Time Frame: 4 to 8 weeks ]

5.  Secondary:   Clinical Global Impression of Severity (CGI-S) Scores at Each Visit   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 8 ]

6.  Secondary:   Clinical Global Impression of Improvement (CGI-I) at Each Visit   [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ]

7.  Secondary:   Patient Global Impression of Improvement (PGI-I) Score at Each Visit   [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ]

8.  Secondary:   Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8   [ Time Frame: Baseline and Weeks 4 and 8 ]

9.  Secondary:   Percentage of Responders   [ Time Frame: 4 to 8 weeks ]

10.  Secondary:   Patients Reaching Remission   [ Time Frame: Week 8 ]

11.  Secondary:   Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

12.  Secondary:   Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication   [ Time Frame: over 8 weeks ]

13.  Secondary:   Number of Patients With Potentially Clinically Significant Laboratory Findings   [ Time Frame: over 8 weeks ]

14.  Secondary:   Discontinuations Due to Adverse Events (AE)   [ Time Frame: over 8 weeks ]

15.  Secondary:   Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study   [ Time Frame: over 8 weeks ]

16.  Secondary:   Change From Baseline to Week 4 and Week 8 in Weight   [ Time Frame: Baseline to Weeks 4 and 8 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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


Publications of Results:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00422162     History of Changes
Other Study ID Numbers: 10614, F1J-BI-HMES
Study First Received: January 11, 2007
Results First Received: August 25, 2009
Last Updated: July 22, 2011
Health Authority: Russia: Pharmacological Committee, Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
South Africa: National Health Research Ethics Council
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)