Phase 3 N=1,075 Treatment

Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study

Depressive Disorder, Major

Bottom Line

View on ClinicalTrials.gov: NCT01152996 ↗

Enrolled (actual)

1,075

Serious AEs

2.7%

Results posted

May 2014

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5% — 258; 80; 68; 65 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vortioxetine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%	258; 80; 68; 65; 68; 66	—
PRIMARY Number of Participants With Serious Treatment-Emergent Adverse Events	29	—
PRIMARY Treatment-Emergent Adverse Events Leading to Study Discontinuation	117	—
SECONDARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	-2.7; -4.8; -6.1; -7.9; -8.5; -9.1	—
SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score	-2.6; -4.2; -4.8	—
SECONDARY Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)	-0.6; -1.0; -1.2	—
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score	-2.8; -3.9; -4.0; -4.7	—
SECONDARY Change From Baseline in SDS Work/School Subscale	-0.8; -1.2; -1.2; -1.4	—
SECONDARY Change From Baseline in SDS Social Life Subscale	-1.0; -1.4; -1.4; -1.6	—
SECONDARY Change From Baseline in SDS Family Life/Home Responsibilities Subscale	-0.9; -1.3; -1.4; -1.6	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01152996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.