Clinical trial NCT01152996: Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
Official title: A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg) in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Depression
Melancholia
Paraphrenia
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 1075
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
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 safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.

Detailed description: Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.

This is a multicenter extension study designed to allow eligible patients who have completed short-term efficacy and safety studies LuAA21004_315 (NCT01153009), LuAA21004_316 (NCT01163266) and LuAA21004_317 (NCT01179516) to receive the 52-week treatment with vortioxetine in this open-label extension study. Participants are expected to return to the site for approximately 13 visits.

A safety follow-up call will be made 4 weeks after completion of the 52-week treatment period.

Eligibility criteria: Inclusion Criteria:

* Has completed either study LuAA21004_315 ( NCT01153009), LuAA21004_316 (NCT01163266), or LuAA21004_317 (NCT01179516) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the Week 8 \[Lu AA21004_317\] or Week 10 \[Lu AA21004_315 or Lu AA21004_316\] assessment of the preceding protocol).
* Suffers from a recurrent major depressive episode) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior study.
* Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this participant according to the opinion of the investigator.
* Females of childbearing potential who are sexually active with a nonsterilized male partner agree to routinely use adequate contraception throughout the duration of the study.

Exclusion Criteria:

* Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
* In the investigator's clinical judgment, 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 (MADRS).
* 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: Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%
timeFrame: Over the 52 week period
measure: Number of Participants With Serious Treatment-Emergent Adverse Events
timeFrame: Over the 52 week period
measure: Treatment-Emergent Adverse Events Leading to Study Discontinuation
timeFrame: Over the 52 week period
Secondary outcomes:
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) 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 Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Baseline and Weeks 4, 24, and 52
measure: Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
timeFrame: Baseline and Weeks 4, 24, and 52
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline and Weeks 12, 24, 36, and 52
measure: Change From Baseline in SDS Work/School Subscale
timeFrame: Baseline and Weeks 12, 24, 36, and 52
measure: Change From Baseline in SDS Social Life Subscale
timeFrame: Baseline and Weeks 12, 24, 36, and 52
measure: Change From Baseline in SDS Family Life/Home Responsibilities Subscale
timeFrame: Baseline and Weeks 12, 24, 36, and 52
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Senior Medical Director
role: STUDY_DIRECTOR
References: