Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-02 @ 12:57 PM
Study NCT ID:
NCT02972632
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2016-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).
Detailed Description:
The drug being tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in people who have major depressive disorder. This study will look at effectiveness of treatment with vortioxetine in participant's goal achievement for the treatment of major depressive disorder.
The study enrolled 123 patients. Participants will receive:
• Vortioxetine 10 to 20 mg
All participants will be asked to take one tablet at the same time each day throughout the study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to 20 mg. The dose may then be decreased by 5 mg based on participant's response and tolerability to higher dose as judged by the Investigator.
This multi-center trial will be conducted in Unites States. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.
The study enrolled 123 patients. Participants will receive:
• Vortioxetine 10 to 20 mg
All participants will be asked to take one tablet at the same time each day throughout the study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to 20 mg. The dose may then be decreased by 5 mg based on participant's response and tolerability to higher dose as judged by the Investigator.
This multi-center trial will be conducted in Unites States. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1185-6902 | OTHER | WHO | View |