An open-label, single-arm, Multicenter, prospective, phase 4, interventional, flexible dose study To evaluate the effectiveness of vortioxetine on goal achievement After a change in antidepressant medication for the treatment of Subjects with major depressive disorder
Sponsor: |
Takeda |
Enrolling: |
Male and Female Patients |
Study Length: |
12 Weeks |
Clinic Visits: |
5 |
IRB Number: |
7513 |
U.S. Govt. ID: |
NCT02972632 |
Contact: |
Peter Arden: 646-774-8004 / ardenpe@nyspi.columbia.edu |
Patients who are either interested in discontinuing their current antidepressant or have discontinued an antidepressant in the past 6 weeks will be provided with an FDA approved medicine, Vortioxetine (brand name Trintellix). Treatment with Vortioxetine will start after the past antidepressant is discontinued. Vortioxetine dosage is adjustable throughout the study, and the optimal dose will be determined between the patient and the physician. The study is centered around whether Vortioxetine treatment is able to help patients pursue their self-determined goals over the course of the study.There is no placebo group and all study medication will be supplied at no cost.
This study is closed
Investigator
David Hellerstein, MD
Are you taking an antidepressant you want to discontinue or have you discontinued an antidepressant within the past 6 weeks? |
Yes |
No |
Have you previously been on a mood stabilizer (for example, lithium/depakote) or an MAOI (for example, Parnate)? |
Yes |
No |
Have you previously taken vortioxetine? |
Yes |
No |
Have you take any psychostimulants (Concerta, Ritalin, Adderall, ect.) in the past 6 weeks?l |
Yes |
No |
Are you currently pregnant or planning on becoming pregnant in the next 2 months? |
Yes |
No |