Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: H. Lundbeck A/S
• Treatments: Vortioxetine

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.