Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Inclusion Criteria:

• Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic andStatistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®)criteria (classification code 300.02).

• Has a Hamilton Anxiety Scale total score ≥ 20.

• Has a Hamilton Anxiety Scale score ≥ 2 on both item 1 (anxious mood) and item 2 (tension).

• Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.

Exclusion Criteria:

• Has 1 or more of the following:

• Any current psychiatric disorder other than Generalized Anxiety Disorder asdefined in the DSM-IV-TR (as assessed by the Mini International NeuropsychiatricInterview [MINI]).

• Current or past history of: manic or hypomanic episode, schizophrenia or anyother psychotic disorder, including major depression with psychotic features,mental retardation, organic mental disorders, or mental disorders due to ageneral medical condition as defined in the DSM-IV-TR.

• Any substance disorder (except nicotine and caffeine) within the previous 6months as defined in the DSM-IV-TR and participant must have a negative urinedrug screen prior to Baseline.

• Presence or history of a clinically significant neurological disorder (includingepilepsy).

• Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiplesclerosis, Huntington disease, etc.).

• Any Axis II disorder that might compromise the study.

• Is taking excluded medications.

• Has a significant risk of suicide according to the investigator's opinion or has ascore ≥5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression RatingScale or has made a suicide attempt in the previous 6 months.

• Has previously failed to respond to adequate treatment with selective serotoninreuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.

• Has received electroconvulsive therapy within 6 months prior to Screening.

• Is currently receiving formal cognitive or behavioral therapy, systematicpsychotherapy, or plans to initiate such therapy during the study.

• Has a clinically significant unstable illness.

• Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.

• Has a serum creatinine of > 1.5 × the upper limit of normal.

• Has a previous history of cancer that had been in remission for less than 5 years.

• Has thyroid stimulating hormone value outside the normal range.

• Has an abnormal electrocardiogram.