Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Vortioxetine; Placebo
Intervention description: Encapsulated vortioxetine immediate-release tablets; Vortioxetine placebo-matching capsules
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 457.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; Mood Disorder; Affective Disorder; Anxiety Disorder; Drug Therapy

Summary:

      The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg
      vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and
             Statistical 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 as
                  defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric
                  Interview [MINI]).

               -  Current or past history of: manic or hypomanic episode, schizophrenia or any
                  other psychotic disorder, including major depression with psychotic features,
                  mental retardation, organic mental disorders, or mental disorders due to a
                  general medical condition as defined in the DSM-IV-TR.

               -  Any substance disorder (except nicotine and caffeine) within the previous 6
                  months as defined in the DSM-IV-TR and participant must have a negative urine
                  drug screen prior to Baseline.

               -  Presence or history of a clinically significant neurological disorder (including
                  epilepsy).

               -  Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple
                  sclerosis, 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 a
             score ≥5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating
             Scale or has made a suicide attempt in the previous 6 months.

          -  Has previously failed to respond to adequate treatment with selective serotonin
             reuptake 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, systematic
             psychotherapy, 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.