A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Once Daily Oral Lu AA21004 in Patients With Major Depressive Disorder

Takeda0 sites493 target enrollmentApril 10, 2015

ConditionsMajor Depressive Disorder

InterventionsPlacebo Vortioxetine

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Major Depressive Disorder
Sponsor: Takeda
Enrollment: 493
Primary Endpoint: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Week 8
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of two fixed doses of vortioxetine (Lu AA21004; 10 or 20 mg/day) after 8 weeks of treatment in patients with major depressive disorder (MDD) in Japan.

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel-group, phase III study to assess the efficacy and safety of 8-week treatment of two fixed doses of Vortioxetine (Lu AA21004; 10 or 20 mg/day) in Japanese participants with major depressive disorder (MDD).

Registry

clinicaltrials.gov

Start Date

April 10, 2015

End Date

March 16, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Takeda

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
•The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
•The participant suffers from recurrent MDD as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x).
•The participant is a man or a woman aged 20 to 75 years (both inclusive) at the time of informed consent.
•The reported duration of the current major depressive episode is 3 to 12 months (both inclusive) at the start of screening period.
•The participant has a MADRS total score ≥26, Hamilton Depression Rating Scale (HAM-D17) total score ≥18, and Clinical global impression scale-Severity (CGI-S) score ≥4 at the start of screening period, at the start of placebo lead-in period and at the start of double-blind treatment period.
•A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to the end of the follow-up period.

Exclusion Criteria

•The participant has any following current or past history of psychiatric disorder and/or neurological disorder:
•Any current psychiatric disorder other than MDD as defined by DSM-IV-TR (To be assessed by Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless the participant fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
•Current diagnosis or history of manic, mixed or hypomanic episode, MDD with psychotic features, schizophrenia or any other psychotic disorder (including substance-related mental disorders, or mental disorders due to a general medical condition) as defined by DSM-IV-TR.
•Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined by DSM-IV-TR.
•The participant with a positive urine drug screening result at the start of screening period or the start of placebo lead-in period. In case that a participant showed positive test result at the start of screening period because the test was conducted before washout of pretreatment drug, the participant is eligible as long as he/she shows negative result at the start of placebo lead-in period.
•Presence or history of any clinically significant neurological disorder (including epilepsy).
•Any neurodegenerative disorder (e.g. Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease).
•Any DSM-IV-TR axis II disorder.
•The participant has the current or previous major depressive episode which was considered by the investigator or sub-investigator to have been resistant to 2 or more adequate antidepressants treatments of at least 6 weeks duration each at sufficient doses.
•The participant has received any augmentation therapy (e.g. lithium, T3/T4, lamotrigine, sodium valproate, carbamazepine, additional atypical antipsychotic, or concomitant use of other antidepressant, etc.) for the current major depressive episode.

Arms & Interventions

Placebo

Placebo tablets, orally, once daily for up to Week 8

Intervention: Placebo

Vortioxetine 10 mg

Vortioxetine 10 mg tablets, orally, once daily for up to Week 8

Intervention: Vortioxetine

Vortioxetine 20 mg

Vortioxetine 10 mg tablets, orally, once daily for up to Week 1 followed by vortioxetine 20 mg tablets, orally, once daily for up to Week 8

Intervention: Vortioxetine

Outcomes

Primary Outcomes

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Week 8

Time Frame: Baseline (At the start of double-blind treatment period), up to 8 weeks

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.

Secondary Outcomes

MADRS Response at Week 8 (Last Observation Carried Forward (LOCF))(Week 8)
MADRS Remission at Week 8 (LOCF)(Week 8)
Change From Baseline in Hamilton Depression Scale (HAM-D17) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 (LOCF)(Week 8)
Change From Baseline in Digit Symbol Substitution Test (DSST) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
Change From Baseline in Perceived Deficits Questionnaire (PDQ-5) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
Change From Baseline in Sheehan Disability Scale (SDS) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)