Clinical trial NCT00707980: Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Official title: A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Melancholia
Mood Disorder
Dysthymic Disorder
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2008-07-02
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the long-term 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 people who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine.

The study enrolled 836 patients that had completed one of two other vortioxetine studies. Participants received 5 mg of vortioxetine for the first week of treatment. After completing the first week of treatment, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day based on participant's response as judged by the doctor.

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

This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 56 weeks. Participants made 13 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:

* Has completed the double blind treatment period of either study Lu AA21004_304 (NCT00672620) or LuAA21004_305 (NCT00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
* 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 (classification code 296.xx) at entry into the prior Lu AA21004_304 or Lu AA21004_305 study.

Exclusion Criteria:

* In addition to meeting the exclusion criteria for studies Lu AA21004_304 or Lu AA21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:

  * Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
  * The participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.
  * The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
  * Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
  * Has used/uses disallowed concomitant medication.

Primary outcomes:
measure: Physical Examination Findings
timeFrame: Baseline and Week 52
measure: Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
timeFrame: Weeks 4, 8, 12, 20, 28, 36, 44 and 52
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Weeks 4, 12, 24, 36 and 52
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)
measure: Number of Participants With Potentially Clinically Significant Vital Sign Findings
timeFrame: Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52
Secondary outcomes:
measure: Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.
measure: Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and Weeks 4, 24 and 52
measure: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Baseline and Weeks 4, 24 and 52
measure: Change From Baseline in the Clinical Global Impression of Severity of Illness Scale
timeFrame: Baseline and Weeks 4, 24 and 52
measure: Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
timeFrame: Baseline and Week 52
measure: Change From Baseline to the Final Visit in the Sheehan Disability Scale
timeFrame: Baseline and Week 52
measure: Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
timeFrame: Baseline and Week 52
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
city: Elizabeth Vale
country: Australia
city: Richmond
country: Australia
city: Southport
country: Australia
city: Osijek
country: Croatia
city: Zagreb
country: Croatia
city: Bully les Mines
country: France
city: Marseille
country: France
city: Strasbourg
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Chemnitz
country: Germany
city: Huettenberg
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Nuernberg
country: Germany
city: Wiesbaden
country: Germany
city: Buchon
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Sigulda
country: Latvia
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Kuala Lumpur
country: Malaysia
city: SchHoogfliet
country: Netherlands
city: Wildervank
country: Netherlands
city: Zwijndrecht
country: Netherlands
city: Białystok
country: Poland
city: Leszno
country: Poland
city: Pruszków
country: Poland
city: Skórzewo
country: Poland
city: Toruń
country: Poland
city: Tuszyn
country: Poland
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Belgrade
country: Serbia
city: Bryanston
country: South Africa
city: Durban
country: South Africa
city: Lyttelton
country: South Africa
city: NoordHeuwel
country: South Africa
city: Pretoria
country: South Africa
city: Kaohsiung
country: Taiwan
city: Dnepropetrovsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
city: Simferopol
country: Ukraine
city: Glasgow
country: United Kingdom
Study officials:
affiliation: Takeda
name: Medical Director, Clinical Science
role: STUDY_DIRECTOR
References: