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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00694304
First received: June 6, 2008
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Vortioxetine (Lu AA21004)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Number of Patients With Adverse Events (AEs) [ Time Frame: Baseline to end of the 4-week safety follow-up period ] [ Designated as safety issue: Yes ]
  • Percentage of Patients Who Withdrew Due to Intolerance to Treatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in MADRS Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in CGI-S Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.

  • Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Change From Baseline in SDS Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.


Enrollment: 535
Study Start Date: May 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vortioxetine Drug: Vortioxetine (Lu AA21004)
2.5, 5, or 10 mg/day; tablets; orally
Other Name: Brintellix

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694304

Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Publications:
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00694304     History of Changes
Other Study ID Numbers: 11984B, EudraCT 2007-004992-21
Study First Received: June 6, 2008
Results First Received: October 28, 2013
Last Updated: February 17, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish National Agency for Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hong Kong: Department of Health
India: Drugs Controller General of India
Korea: Food and Drug Administration
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Romania: National Agency for Medicines and Medical Devices
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
Taiwan: National Bureau of Controlled Drugs
Turkey: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by H. Lundbeck A/S:
Major Depressive Disorder
Long-term
Safety
Open-label

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Vortioxetine
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Agents
Serotonin Antagonists
Serotonin Receptor Agonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014