Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; Anxiety Disorders; Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily
      (QD), in adults with Generalized Anxiety Disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suffers from a primary diagnosis of Generalized Anxiety Disorder according to
             Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
             (DSM-IV-TR) criteria.

          -  Has a Hamilton Anxiety Scale total score ≥20 at Screening and Baseline.

          -  Has a Hamilton Anxiety Scale score ≥2 on both Item 1 (anxious mood) and Item 2
             (tension) at Screening and Baseline.

          -  Has a Montgomery-Åsberg Depression Rating Scale total score ≤16 at Screening and
             Baseline.

          -  Male and females of childbearing potential who are sexually active agree to use
             adequate contraception from Screening throughout the duration of the study and for 1
             month after the last dose of study medication.

        Exclusion Criteria:

          -  Has received any investigational compound <30 days before Screening or 5 half-lives
             prior to Screening.

          -  Has received Lu AA21004 in a previous clinical study or as a therapeutic agent.

          -  Has 1 or more of the following:

               -  Any current psychiatric disorder other than Generalized Anxiety Disorder as
                  defined in the DSM-IV-TR.

               -  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.

               -  Presence or history of a clinically significant neurological disorder (including
                  epilepsy).

               -  Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple
                  sclerosis, Huntington disease, etc).

               -  Any Axis II disorder that might compromise the study.

          -  Is required to take excluded medications or it is anticipated that the participant
             will require treatment with at least 1 of the disallowed concomitant medications
             during the study including:

               -  Nonsteroidal anti-inflammatory drugs

               -  Rifampin

               -  Macrolide antibiotics

               -  Hormones

               -  Hypoglycemic agents and Insulin

               -  Systemic steroids

               -  Antineoplastics

               -  Antiobesity agents

               -  Antidiarrheal agents (episodic use allowed)

               -  Antifungal agents (episodic topical use allowed)

               -  Antihistamines (episodic use of loratadine, desloratadine, cetirizine allowed)

               -  Cough/cold agents (episodic use allowed but preparations containing
                  pseudoephedrine and narcotics are NOT allowed)

               -  Diuretics (episodic use allowed)

          -  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, for example, hepatic impairment or
             renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine,
             neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue
             disorders, or metabolic disturbance.

          -  Has an alanine aminotransferase, aspartate aminotransferase or bilirubin level >1.5
             times the upper limits of normal.

          -  Has a serum creatinine of >1.5 times the upper limits of normal.

          -  Has a previous history of cancer that had been in remission for less than 5 years
             prior to the first dose of study medication. This criterion does not include those
             participants with basal cell or stage I squamous cell carcinoma of the skin.

          -  Has clinically significant abnormal vital signs as determined by the investigator.

          -  Has 1 or more laboratory values outside the normal range, based on the blood or urine
             samples taken at Screening, that are considered by the investigator to be clinically
             significant.

          -  Has thyroid stimulating hormone value outside the normal range at Screening and is
             deemed clinically significant by the investigator.

          -  Has an abnormal electrocardiogram as determined by the central reader and confirmed as
             clinically significant by the investigator.

          -  Has a disease or takes medication that, in the opinion of the investigator, could
             interfere with the assessments of safety, tolerability, or efficacy.

          -  Has previously participated in this study.