Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
NCT00694304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 535
Last updated 2014-04-01
Summary
The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.
Conditions
Interventions
- DRUG
-
Vortioxetine (Lu AA21004)
2.5, 5, or 10 mg/day; tablets; orally
Sponsors & Collaborators
-
H. Lundbeck A/S
lead INDUSTRY
Principal Investigators
-
Email contact via H. Lundbeck A/S · [email protected]
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2010-03-31
- Completion
- 2010-04-30
More Related Trials
-
Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT01163266 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT01179516 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
NCT00596817 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT00735709 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
NCT00672620 ·Status: COMPLETED ·Phase: PHASE3
-
Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction
NCT01364649 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
NCT01255787 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Phase 3 Study of Lu AA21004 in Patients With Major Depressive Disorder
NCT02389816 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
NCT01491035 ·Status: COMPLETED ·Phase: PHASE2
-
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
NCT02871297 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder
NCT01422213 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
NCT01355081 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
NCT01488071 ·Status: COMPLETED ·Phase: PHASE3
-
Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression
NCT03766867 ·Status: COMPLETED ·Phase: PHASE2
-
Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
NCT03108625 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder
NCT01564862 ·Status: COMPLETED ·Phase: PHASE2
-
Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls
NCT01607125 ·Status: COMPLETED ·Phase: PHASE1
-
Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
NCT04288895 ·Status: COMPLETED ·Phase: PHASE4
-
Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease
NCT02454426 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
The Relationship Among Changes in Brain Network Activation in Adult Outpatients With Major Depressive Disorder
NCT02749721 ·Status: COMPLETED ·Phase: PHASE4
-
Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine
NCT02969876 ·Status: TERMINATED ·Phase: PHASE4
-
Long-Term Extension Study of Lu AA21004 in Participants With Major Depressive Disorder
NCT01395147 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
NCT02279953 ·Status: COMPLETED ·Phase: PHASE3
-
Real-life Effectiveness of Vortioxetine in Depression
NCT03555136 ·Status: COMPLETED
-
Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder
NCT02279966 ·Status: COMPLETED ·Phase: PHASE3