A Study in the Treatment of Children and Adolescents With... | NCT00849901

ID	Type	Description	Link
F1J-MC-HMCK	Other Identifier	Eli Lilly and Company

Status Module

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
Fluoxetine	Active Comparator	Drug: fluoxetine
Duloxetine	Experimental	Drug: duloxetine

Name	Type	Description	Arm Group Labels	Other Names
duloxetine	Drug	30-120 mg, PO, QD, for up to 38 weeks	Duloxetine	LY248686

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint	CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatmentvisit, age categoryvisit and baseline*visit.	Baseline, Week 10

Secondary Outcomes

Measure	Description	Time Frame
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint	CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age categoryvisit and baselinevisit.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatient, diagnosed with major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and supported by the Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID).
Diagnosis of moderate or greater severity of MDD as determined by Children's Depression Rating Scale - Revised (CDRS-R) with a total score greater than or equal to 40 at screen, and randomization and a Clinical Global Impression of Severity (CGI-Severity) rating of greater than or equal to 4 at screen, and randomization.
Female patients must test negative for pregnancy during screening.
Judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol.
Has a degree of understanding such that they can communicate intelligently with the investigator and study coordinator.
Capable of swallowing study drug whole. It is anticipated the patients will need to swallow up to 6 capsules per day.
Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol.

Exclusion Criteria:

Children of site personnel directly affiliated with this study and/or their immediate families.
Children of Lilly employees or employees of the designated clinical research organization (CRO) assisting with the conduct of the study.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder, as judged by the investigator.
Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine.
Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary DSM-IV-TR Axis I disorder that requires any pharmacologic treatment
Have 1 or more first-degree relatives with diagnosed bipolar I disorder.
Have a significant suicide attempt within 1 year of screening or are currently at risk of suicide in the opinion of the investigator.
Have a weight less than 20 kilogram (kg) at screening.
Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode.
Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to screening.
Have a history of seizure disorder (other than febrile seizures).
Have a history of electroconvulsive therapy within 1 year of screening.
Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or fluoxetine within 30 days of randomization; or the potential need to use an MAOI during the study or within 5 weeks of discontinuation of study drug.
Have previously enrolled, completed, or withdrawn from this study or any other study investigating duloxetine or fluoxetine.
Have a positive urine drug screen for any substances of abuse or excluded medication.
Are taking any excluded medications that cannot be discontinued by screening.
Have known hypersensitivity to duloxetine, fluoxetine, or their inactive ingredients; or have frequent or severe allergic reactions to multiple medications.
Have uncontrolled narrow-angle glaucoma.
Have acute liver injury or severe cirrhosis.
Have a serious or unstable medical illness, psychological condition, or clinically significant laboratory or electrocardiogram (ECG) result that, in the opinion of the investigator, would compromise participation in the study or be likely to lead to hospitalization.
Have abnormal thyroid-stimulating hormone concentration.
Have initiated or discontinued hormone therapy within the previous 3 months.
Female patients who are either pregnant, nursing or have recently given birth.
Need to use thioridazine during the study or within 5 weeks after discontinuation of study drug or need to use pimozide during the study.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Costa Mesa	California	92626

PubMed Identifier	Type	Citation	Retractions
25978741	Derived	Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.
24813026	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
FG001	Fluoxetine/Fluoxetine

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00013.14± 3.043 BG00113.08± 3.272 BG00213.28± 3.055 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00064 BG00161 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0001 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00050 BG00145 BG002

Children's Depression Rating Scale-Revised (CDRS-R) Total Score

CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00059.2± 10.45 BG001

CDRS-R Subscale Scores

CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Mood

Title	Measurements
	BG00016.3± 3.54 BG001

Clinical Global Impressions of Severity (CGI-Severity) score

CGI-Severity score evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0004.5± 0.62 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint

Participants with both a baseline and at least one post-baseline value.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 10

ID	Title	Description
OG000	Duloxetine	Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
OG001	Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
OG002	Placebo	Received placebo PO, QD during acute treatment phase

Units	Counts
Participants	OG000113 OG001113 OG002103

Title

Denominators

Categories

Title	Measurements
	OG000-24.3± 1.09 OG001-23.7± 1.06 OG002-24.3± 1.11

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis		0.999							95							Superiority or Other

Secondary

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint

Participants with value during treatment phase and at least one post-Week 10 value.

Posted

Least Squares Mean

Standard Deviation

units on a scale

Week 10, Week 36

ID	Title	Description
OG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
OG001	Fluoxetine/Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
OG002	Placebo/Duloxetine	Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase

Secondary

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint

CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.

Participants with both a baseline and at least one post-baseline value.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 10

ID	Title	Description
OG000	Duloxetine	Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
OG001	Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
OG002	Placebo	Received placebo PO, QD during acute treatment phase

Secondary

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint

Participants with value during treatment phase and at least one post-Week 10 value.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 10, Week 36

ID	Title	Description
OG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
OG001	Fluoxetine/Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
OG002	Placebo/Duloxetine	Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase

Secondary

Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint

CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.

Participants with both a baseline and at least one post-baseline value.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 10

ID	Title	Description
OG000	Duloxetine	Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
OG001	Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
OG002	Placebo	Received placebo PO, QD during acute treatment phase

Units	Counts

Secondary

Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint

Participants with value during treatment phase and at least one post-Week 10 value.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 10, Week 36

ID	Title	Description
OG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
OG001	Fluoxetine/Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
OG002	Placebo/Duloxetine	Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase

Secondary

Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10

Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0).

Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.

Posted

Number

participants

Baseline through Week 10

ID	Title	Description
OG000	Duloxetine	Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
OG001	Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
OG002	Placebo	Received placebo PO, QD during acute treatment phase

Secondary

Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36

Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.

Posted

Number

participants

Week 10 through Week 36

ID	Title	Description
OG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
OG001	Fluoxetine/Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
OG002	Placebo/Duloxetine

Secondary

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10

Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.

Participants with normal ALT value (ALT <1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.

Posted

Number

participants

Baseline through Week 10

ID	Title	Description
OG000	Duloxetine	Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
OG001	Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
OG002	Placebo	Received placebo PO, QD during acute treatment phase

Secondary

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36

Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.

Posted

Number

participants

Week 10 through Week 36

ID	Title	Description
OG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
OG001	Fluoxetine/Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
OG002	Placebo/Duloxetine	Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase

Secondary

Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10

PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.

Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.

Posted

Number

percentage of participants

Baseline through Week 10

ID	Title	Description
OG000	Duloxetine	Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
OG001	Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
OG002	Placebo

Secondary

Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36

PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.

Participants with normal value at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.

Posted

Number

percentage of participants

Week 10 through Week 36

ID	Title	Description
OG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
OG001	Fluoxetine/Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
OG002	Placebo/Duloxetine

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Duloxetine - Acute	Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase	3	117	70	117
EG001	Fluoxetine - Acute	Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase	2	117	72	117
EG002	Placebo - Acute	Received placebo PO, QD during acute treatment phase	1	103	68	103
EG003	Duloxetine - Extension	Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase	1	83	53	83
EG004	Fluoxetine - Extension	Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section).	4	92	56	92
EG005	Placebo/Duloxetine - Extension	Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase	4	86	60	86

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0011 events1 affected117 at risk EG0020 events0 affected103 at risk EG0030 events0 affected83 at risk EG0040 events0 affected92 at risk EG0050 events0 affected86 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0011 events1 affected117 at risk EG0020 events0 affected103 at risk EG003
Pilonidal cyst	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0011 events1 affected117 at risk EG0020 events0 affected103 at risk EG003
Convulsion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Adjustment disorder with disturbance of conduct	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Conversion disorder	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Drug abuse	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Hypomania	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Major depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0021 events1 affected103 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Social phobia	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0010 events0 affected117 at risk EG0020 events0 affected103 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0012 events2 affected117 at risk EG0025 events5 affected103 at risk EG0031 events1 affected83 at risk EG0042 events2 affected92 at risk EG0051 events1 affected86 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0004 events4 affected117 at risk EG0017 events5 affected117 at risk EG0028 events7 affected103 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0006 events6 affected117 at risk EG0012 events2 affected117 at risk EG0022 events2 affected103 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00028 events20 affected117 at risk EG00117 events15 affected117 at risk EG00214 events11 affected103 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0007 events7 affected117 at risk EG0017 events6 affected117 at risk EG0023 events3 affected103 at risk EG003
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment	EG0008 events8 affected117 at risk EG0015 events3 affected117 at risk EG0025 events5 affected103 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected117 at risk EG0011 events1 affected117 at risk EG0022 events2 affected103 at risk EG003
Influenza	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0007 events7 affected117 at risk EG0013 events3 affected117 at risk EG0028 events6 affected103 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0014 events4 affected117 at risk EG0025 events5 affected103 at risk EG003
Sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0011 events1 affected117 at risk EG0023 events3 affected103 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 events4 affected117 at risk EG0013 events3 affected117 at risk EG0021 events1 affected103 at risk EG003
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0015 events4 affected117 at risk EG0023 events3 affected103 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00011 events10 affected117 at risk EG00110 events10 affected117 at risk EG0027 events7 affected103 at risk EG003
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00011 events10 affected117 at risk EG0014 events4 affected117 at risk EG0023 events3 affected103 at risk EG003
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00023 events19 affected117 at risk EG00122 events18 affected117 at risk EG00210 events9 affected103 at risk EG003
Somnolence	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0007 events7 affected117 at risk EG0016 events6 affected117 at risk EG0026 events6 affected103 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0008 events6 affected117 at risk EG0016 events6 affected117 at risk EG0022 events2 affected103 at risk EG003

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011437	Propylamines
D000588	Amines

ID	Title	Description
BG000	Duloxetine/Duloxetine	Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
BG001	Fluoxetine/Fluoxetine	Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
BG002	Placebo/Duloxetine	Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
BG003	Total	Total of all reporting groups