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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
Enrollment 176

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 88 88
Safety Analysis Set 88 87
Completed 56 49
Not Completed 32 39
Reason Not Completed
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
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 88 88 176
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 88 participants 176 participants
38.63  (12.18) 41.45  (12.44) 40.04  (12.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 88 participants 176 participants
Female
41
  46.6%
36
  40.9%
77
  43.8%
Male
47
  53.4%
52
  59.1%
99
  56.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 88 participants 176 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 88 participants 176 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  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 88 participants 88 participants 176 participants
88 88 176
Montgomery-Äsberg Depression Rating Scale (MADRS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 88 participants 88 participants 176 participants
32.1  (5.3) 31.8  (4.8) 32.0  (5.0)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 88 participants 88 participants 176 participants
24.6  (2.6) 25.0  (2.6) 24.8  (2.6)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 88 participants 88 participants 176 participants
4.9  (0.6) 4.9  (0.7) 4.9  (0.7)
[1]
Measure Description: 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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 88 participants 176 participants
29.92  (12.61) 34.07  (12.69) 30.00  (12.79)
Years Since the First MDD Episode  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 88 participants 176 participants
8.71  (6.21) 7.38  (7.86) 8.05  (7.10)
Years Since the Most Recent MDD Episode  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 88 participants 176 participants
3.66  (5.12) 3.23  (4.15) 3.45  (4.65)
Number of Previous Lifetime MDD Episodes  
Mean (Standard Deviation)
Unit of measure:  Number of MDD Episodes
Number Analyzed 88 participants 88 participants 176 participants
1.4  (1.4) 1.3  (2.1) 1.3  (1.8)
Number of Previous MDD Episodes Within the Last 36 Months  
Mean (Standard Deviation)
Unit of measure:  Number of MDD Episodes
Number Analyzed 88 participants 88 participants 176 participants
0.5  (0.8) 0.5  (1.1) 0.5  (0.9)
1.Primary Outcome
Title Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)
Hide Description The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 87 86
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-15.92  (1.20) -14.30  (1.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine + Fluoxetine, Placebo + Fluoxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.62
Confidence Interval (2-Sided) 95%
-5.04 to 1.80
Estimation Comments The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.
2.Secondary Outcome
Title Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale
Hide Description CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 87 86
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.43  (0.15) -1.63  (0.16)
3.Secondary Outcome
Title Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)
Hide Description SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 88 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.03  (1.71) -0.14  (1.72)
4.Secondary Outcome
Title Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)
Hide Description SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 88 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Functioning 2.20  (7.51) 0.70  (7.47)
Role-Physical 3.99  (11.79) 3.93  (11.23)
Bodily Pain 6.81  (12.05) 0.02  (11.30)
General Health 5.82  (11.49) 2.84  (9.44)
Vitality 7.43  (13.54) 5.04  (9.83)
Social Functioning 6.13  (13.55) 4.56  (11.78)
Role-Emotional 6.61  (12.39) 6.71  (12.12)
Mental Health 8.98  (13.46) 8.43  (11.99)
Mental Component Score 8.87  (14.29) 8.73  (12.54)
Physical Component Score 2.87  (7.59) -0.65  (7.22)
5.Secondary Outcome
Title Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)
Hide Description SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 88 88
Mean (Standard Error)
Unit of Measure: Units on a scale
Work/School (n=68,65) -1.34  (2.71) -1.55  (2.89)
Social Life (n=79,79) -1.70  (2.66) -1.49  (2.85)
Family Life (n=79,78) -1.63  (3.00) -1.53  (2.66)
SDS Total Score (68,64) -4.57  (7.75) -4.41  (7.89)
6.Secondary Outcome
Title Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score
Hide Description The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.
Time Frame Baseline,8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 87 86
Measure Type: Number
Unit of Measure: Percent of participants
65.5 61.2
7.Secondary Outcome
Title Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks
Hide Description The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 87 86
Measure Type: Number
Unit of Measure: Percent of participants
37.9 38.8
8.Secondary Outcome
Title Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)
Hide Description BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient’s awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 88 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.01  (2.24) -0.04  (2.13)
9.Secondary Outcome
Title Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)
Hide Description AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant’s incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.
Time Frame Baseline, 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 88 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.16  (1.47) -0.31  (3.28)
Time Frame [Not Specified]
Adverse Event Reporting Description All participants in the safety analysis set.
 
Arm/Group Title Olanzapine + Fluoxetine Placebo + Fluoxetine
Hide Arm/Group Description

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 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.

All-Cause Mortality
Olanzapine + Fluoxetine Placebo + Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Olanzapine + Fluoxetine Placebo + Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/88 (1.14%)      1/87 (1.15%)    
Psychiatric disorders     
Restlessness  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Suicide attempt  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olanzapine + Fluoxetine Placebo + Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/88 (62.50%)      45/87 (51.72%)    
Cardiac disorders     
Angina pectoris  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Cardiovascular insufficiency  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Palpitations  1  1/88 (1.14%)  1 2/87 (2.30%)  2
Sinus bradycardia  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Supraventricular extrasystoles  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Tachycardia  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Ear and labyrinth disorders     
Tinnitus  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Eye disorders     
Vision blurred  1  2/88 (2.27%)  2 2/87 (2.30%)  2
Gastrointestinal disorders     
Abdominal pain upper  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Diarrhoea  1  0/88 (0.00%)  0 2/87 (2.30%)  2
Dry mouth  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Haematochezia  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Nausea  1  0/88 (0.00%)  0 4/87 (4.60%)  4
Retching  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Salivary hypersecretion  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Tongue disorder  1  1/88 (1.14%)  1 0/87 (0.00%)  0
General disorders     
Asthenia  1  2/88 (2.27%)  2 3/87 (3.45%)  3
Chest discomfort  1  1/88 (1.14%)  1 2/87 (2.30%)  2
Chest pain  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Discomfort  1  0/88 (0.00%)  0 2/87 (2.30%)  2
Fatigue  1  3/88 (3.41%)  3 1/87 (1.15%)  1
Gait disturbance  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Hunger  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Oedema  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Sensation of foreign body  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Thirst  1  2/88 (2.27%)  2 0/87 (0.00%)  0
Hepatobiliary disorders     
Hepatic function abnormal  1  6/88 (6.82%)  6 1/87 (1.15%)  1
Liver disorder  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Liver injury  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Infections and infestations     
Nasopharyngitis  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Upper respiratory tract infection  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Injury, poisoning and procedural complications     
Overdose  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Skin injury  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Investigations     
Alanine aminotransferase increased  1  7/88 (7.95%)  7 1/87 (1.15%)  1
Aspartate aminotransferase increased  1  5/88 (5.68%)  5 0/87 (0.00%)  0
Blood bilirubin increased  1  1/88 (1.14%)  1 2/87 (2.30%)  2
Blood cholesterol increased  1  5/88 (5.68%)  5 1/87 (1.15%)  1
Blood creatine phosphokinase increased  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Blood glucose increased  1  2/88 (2.27%)  2 1/87 (1.15%)  1
Blood pressure increased  1  2/88 (2.27%)  2 0/87 (0.00%)  0
Blood prolactin increased  1  9/88 (10.23%)  9 2/87 (2.30%)  2
Blood triglycerides increased  1  7/88 (7.95%)  7 3/87 (3.45%)  3
Electrocardiogram abnormal  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Electrocardiogram t wave abnormal  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Gamma-glutamyltransferase increased  1  3/88 (3.41%)  3 0/87 (0.00%)  0
High density lipoprotein decreased  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Lipids increased  1  3/88 (3.41%)  3 0/87 (0.00%)  0
Low density lipoprotein increased  1  3/88 (3.41%)  3 1/87 (1.15%)  1
Transaminases increased  1  3/88 (3.41%)  3 0/87 (0.00%)  0
Weight decreased  1  1/88 (1.14%)  1 4/87 (4.60%)  4
Weight increased  1  8/88 (9.09%)  8 2/87 (2.30%)  2
White blood cell count decreased  1  0/88 (0.00%)  0 2/87 (2.30%)  2
Metabolism and nutrition disorders     
Decreased appetite  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Diabetes mellitus  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Dyslipidaemia  1  2/88 (2.27%)  2 0/87 (0.00%)  0
Hyperlipidaemia  1  4/88 (4.55%)  4 1/87 (1.15%)  1
Increased appetite  1  6/88 (6.82%)  6 1/87 (1.15%)  1
Musculoskeletal and connective tissue disorders     
Joint swelling  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Pain in extremity  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  0/41 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
Akathisia  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Dizziness  1  3/88 (3.41%)  3 5/87 (5.75%)  5
Extrapyramidal disorder  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Headache  1  2/88 (2.27%)  2 3/87 (3.45%)  3
Hypokinesia  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Somnolence  1  15/88 (17.05%)  17 3/87 (3.45%)  4
Syncope  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Tremor  1  1/88 (1.14%)  2 0/87 (0.00%)  0
Psychiatric disorders     
Dysphoria  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Fear  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Initial insomnia  1  0/88 (0.00%)  0 2/87 (2.30%)  2
Insomnia  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Mental disorder  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Nervousness  1  2/88 (2.27%)  2 2/87 (2.30%)  3
Restlessness  1  2/88 (2.27%)  2 3/87 (3.45%)  3
Sleep disorder  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Somatic delusion  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Suicidal ideation  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Renal and urinary disorders     
Urine odour abnormal  1  1/88 (1.14%)  1 0/87 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hiccups  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Respiratory tract congestion  1  0/88 (0.00%)  0 1/87 (1.15%)  1
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  2/88 (2.27%)  2 3/87 (3.45%)  3
Vascular disorders     
Hypertension  1  1/88 (1.14%)  1 1/87 (1.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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.
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