Clinical trial NCT00672620: Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Drug Therapy
Major Depressive Episode
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2008-05-06
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

Detailed description: The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 611 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 2.5 mg
* Vortioxetine 5 mg
* Duloxetine 10 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 12 weeks. Participants made 8 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
* The reported duration of the current major depressive episode is at least 3 months.

Exclusion Criteria:

* Has 1 or more the following:

  * Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
  * Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
  * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
  * Presence or history of a clinically significant neurological disorder (including epilepsy).
  * Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
  * Any Axis II disorder that might compromise the study.
* Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
* The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
* Has received electroconvulsive therapy within 6 months prior to Screening.
* Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.

Primary outcomes:
measure: Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
timeFrame: Baseline and Weeks 1, 2, 4, and 6
measure: Percentage of Responders in HAM-D 24 Total Score by Study Visit
timeFrame: Baseline and Weeks 1, 2, 4, 6 and 8.
measure: Percentage of Participants With a Sustained Response in HAM-D24
timeFrame: Baseline to Week 8
measure: Percentage of Participants in MADRS Remission at Week 8
timeFrame: Week 8
measure: Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and Weeks 1, 2, 4, 6 and 8
measure: Clinical Global Impression Scale-Global Improvement Scale
timeFrame: Baseline and Weeks 1, 2, 4, 6 and 8.
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)
timeFrame: Baseline and Weeks 1, 4 and 8
measure: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Baseline and Weeks 1, 2, 4, 6 and 8.
measure: Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale
timeFrame: Baseline and Weeks 1, 2, 4, 6 and 8.
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
timeFrame: Baseline and Week 8
measure: Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Irvine,
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Upland
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Coral Springs,
country: United States
state: Florida
city: Fort Walton Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami,
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Chicago,
country: United States
state: Illinois
city: Libertyville
country: United States
state: Illinois
city: Oak Brook
country: United States
state: Illinois
city: Prairie Village
country: United States
state: Kansas
city: Owensboro,
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Pittsfield
country: United States
state: Massachusetts
city: Worcester,
country: United States
state: Massachusetts
city: Flowood
country: United States
state: Mississippi
city: New York
country: United States
state: New York
city: Olean
country: United States
state: New York
city: Beachwood
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City,
country: United States
state: Oklahoma
city: Allenton
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City,
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Takeda
name: Medical Director, Clinical Science
role: STUDY_DIRECTOR
References:
citation: Mahableshwarkar AR, Jacobsen PL, Chen Y. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder. Curr Med Res Opin. 2013 Mar;29(3):217-26. doi: 10.1185/03007995.2012.761600. Epub 2013 Jan 17.