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Completed

NCT Number: NCT00694304

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A

Exclusion criteria

  • Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., 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

2.5, 5, or 10 mg/day; tablets; orally

Other names: Brintellix

Primary outcomes

  1. Number of Patients With Adverse Events (AEs)

    Time frame: Baseline to end of the 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. Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment

    Time frame: Baseline and Week 52

    The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.

  4. Change From Baseline in CGI-S Score After 52 Weeks of Treatment

    Time frame: Baseline and Week 52

    The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.

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

    Time frame: Week 52

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

    Time frame: Week 52

  7. Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment

    Time frame: Baseline and Week 52

  8. Change From Baseline in SDS Total Score After 52 Weeks of Treatment

    Time frame: Baseline and Week 52

    The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2008
Registry last updated
Apr 1, 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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