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A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression

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ClinicalTrials.gov Identifier: NCT01687478
Recruitment Status : Terminated (Interim assessment: Lack of efficacy)
First Posted : September 19, 2012
Results First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Treatment Resistant Depression
Interventions: Drug: Olanzapine
Drug: Fluoxetine
Drug: Placebo

  Participant Flow

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 + Fluoxetine

Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.

Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.

Placebo + Fluoxetine

Placebo matches the Olanzapine tablet for blinding.

Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.


Participant Flow:   Overall Study
    Olanzapine + Fluoxetine   Placebo + Fluoxetine
STARTED   88   88 
Safety Analysis Set   88   87 
COMPLETED   56   49 
NOT COMPLETED   32   39 
Adverse Event                3                10 
Lost to Follow-up                1                3 
Protocol Violation                0                2 
Withdrawal by Subject                21                19 
Physician Decision                1                3 
Entry Criteria Not Met                6                2 



  Baseline Characteristics

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.

Reporting Groups
  Description
Olanzapine + Fluoxetine

Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.

Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.

Placebo + Fluoxetine

Placebo matches the Olanzapine tablet for blinding.

Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.

Total Total of all reporting groups

Baseline Measures
   Olanzapine + Fluoxetine   Placebo + Fluoxetine   Total 
Overall Participants Analyzed 
[Units: Participants]
 88   88   176 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.63  (12.18)   41.45  (12.44)   40.04  (12.36) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      41  46.6%      36  40.9%      77  43.8% 
Male      47  53.4%      52  59.1%      99  56.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      88 100.0%      88 100.0%      176 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      88 100.0%      88 100.0%      176 100.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      0   0.0%      0   0.0%      0   0.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
China   88   88   176 
Montgomery-Äsberg Depression Rating Scale (MADRS) Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 32.1  (5.3)   31.8  (4.8)   32.0  (5.0) 
[1] The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
17 Item Hamilton Rating Scale for Depression (HAM-D17) Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 24.6  (2.6)   25.0  (2.6)   24.8  (2.6) 
[1] The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Clinical Global Impressions-Severity of Depression (CGI-S) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.9  (0.6)   4.9  (0.7)   4.9  (0.7) 
[1] The CGI-S 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 participants).
Age of First Major Depressive Disorder (MDD) Episode 
[Units: Years]
Mean (Standard Deviation)
 29.92  (12.61)   34.07  (12.69)   30.00  (12.79) 
Years Since the First MDD Episode 
[Units: Years]
Mean (Standard Deviation)
 8.71  (6.21)   7.38  (7.86)   8.05  (7.10) 
Years Since the Most Recent MDD Episode 
[Units: Years]
Mean (Standard Deviation)
 3.66  (5.12)   3.23  (4.15)   3.45  (4.65) 
Number of Previous Lifetime MDD Episodes 
[Units: Number of MDD Episodes]
Mean (Standard Deviation)
 1.4  (1.4)   1.3  (2.1)   1.3  (1.8) 
Number of Previous MDD Episodes Within the Last 36 Months 
[Units: Number of MDD Episodes]
Mean (Standard Deviation)
 0.5  (0.8)   0.5  (1.1)   0.5  (0.9) 


  Outcome Measures

1.  Primary:   Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)   [ Time Frame: Baseline, 8 Weeks ]

2.  Secondary:   Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale   [ Time Frame: Baseline, 8 Weeks ]

3.  Secondary:   Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)   [ Time Frame: Baseline, 8 Weeks ]

4.  Secondary:   Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)   [ Time Frame: Baseline, 8 Weeks ]

5.  Secondary:   Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)   [ Time Frame: Baseline, 8 Weeks ]

6.  Secondary:   Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score   [ Time Frame: Baseline,8 Weeks ]

7.  Secondary:   Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks   [ Time Frame: Baseline, 8 Weeks ]

8.  Secondary:   Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)   [ Time Frame: Baseline, 8 Weeks ]

9.  Secondary:   Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)   [ Time Frame: Baseline, 8 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01687478     History of Changes
Other Study ID Numbers: 13702
F1D-CR-HGNB ( Other Identifier: Eli Lilly and Company )
First Submitted: September 7, 2012
First Posted: September 19, 2012
Results First Submitted: November 16, 2016
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017