A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Inclusion Criteria

- Meet criteria for primary JPFS

- Have a score of greater than or equal to 4 on Brief Pain Inventory (BPI) average pain
severity (Item 3) during screening

- Female participants must have a negative serum pregnancy test during screening

- Participant's parent/legal representative and participant judged to be reliable to
keep all appointments for clinical tests and procedures

- Participant's parent/legal representative and participant must have a degree of
understanding such that they can communicate intelligently

- Participants must be capable of swallowing investigational product whole

- Participants must have venous access sufficient to allow blood sampling and be
compliant with blood draws

Exclusion Criteria:

- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial
involving an investigational drug or device or off-label use of a drug or device or
concurrently enrolled in any other type of medical research

- Previously completed or withdrawn after randomization from a study investigating
duloxetine

- Known hypersensitivity to duloxetine or any of the inactive ingredients, or have
frequent or severe allergic reactions to multiple medications

- Treated with duloxetine within the last 6 months. Will not likely benefit from
duloxetine treatment, in the opinion of the investigator or have had prior nonresponse
or inadequate tolerance to duloxetine

- Pain symptoms related to traumatic injury, past surgery, structural bone or joint
disease or regional pain syndrome that will interfere with interpretation of outcome
measures

- Currently have evidence of rheumatologic disorder or have a current diagnosis of
rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an
autoimmune disease (for example, systemic lupus erythematosus)

- Have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
Axis I condition, currently or within the past year, except major depressive disorder
(MDD) and/or generalized anxiety disorder (GAD), adjustment disorder or specific
phobias with primary investigator approval

- Have a current secondary DSM-IV Axis I condition of attention-deficit/hyperactivity
disorder that requires pharmacologic treatment

- Lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective
disorder

- DSM-IV Axis II disorder which would interfere with protocol compliance

- History of substance abuse or dependence within the 6 months

- Positive urine drug screen for any substances of abuse or excluded medication

- Family history of 1 or more first-degree relatives with diagnosed bipolar I disorder

- Significant suicide attempt within 1 year of screening or are currently at suicidal
risk in the opinion of the investigator

- Weight less than 20 kilogram (kg) at screening

- History of seizure disorder (other than febrile seizures)

- Taking any excluded medications that cannot be discontinued at screening

- Fluoxetine within 30 days prior to completion of screening

- Monoamine oxidase inhibitor (MAOI) within 14 days of screening; or the potential need
to use an MAOI during the study or within 5 days of discontinuation of investigational
product

- Abnormal thyroid-stimulating hormone (TSH) concentrations

- Uncontrolled narrow-angle glaucoma

- Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)

- Serious or unstable medical illness

- Female participants who are either pregnant, nursing or have recently given birth