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Duloxetine is indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine was established in four short-term and one maintenance trial in adults . [see Clinical Studies ( )] 14.1 A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. Duloxetine is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine was established in three short-term trials and one maintenance trial in adults . [see Clinical Studies ( )] 14.2 Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance. Duloxetine is indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy . [see Clinical Studies ( )] 14.3 Duloxetine is indicated for the management of fibromyalgia (FM) . [see Clinical Studies ( )] 14.4 Duloxetine is indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis . [see Clinical Studies ( )] 14.5