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OpenTrials
Completed

NCT Number: NCT00761306

Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

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 6-week acute treatment in study NCT00839423 / 11492A.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period

Exclusion criteria

  • Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR)
  • Female patients of childbearing potential who are not using effective contraception
  • Use of any psychoactive medication

Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Vortioxetine (Lu AA21004)

Drug

5 or 10 mg/day; tablets; orally

Other names: Brintellix

Primary outcomes

  1. Number of Patients With Adverse Events (AEs)

    Time frame: Up to 52 weeks and a 4-week safety follow-up period

  2. Percentage of Patients Who Withdrew Due to Intolerance to Treatment

    Time frame: Baseline to Week 52

Secondary outcomes

  1. Change From Baseline in MADRS Total Score After 52 Weeks of Treatment

    Time frame: Baseline and Week 52

    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.

  2. Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment

    Time frame: Baseline and Week 52

    The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.

  3. Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)

    Time frame: Week 52

  4. Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Long-term, Open-label Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 29, 2008
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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