Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

NCT ID: NCT01355081

Last Updated: 2014-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder.

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.

Detailed Description

Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder. Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy. This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period. Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study. Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.

Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder.

Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy.

This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week s safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period.

Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study.

Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vortioxetine 5 mg

Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Vortioxetine tablets

Vortioxetine 10 mg

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

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Vortioxetine tablets

Placebo

Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vortioxetine placebo

Interventions

Vortioxetine

Vortioxetine tablets

Intervention Type: DRUG

Placebo

Vortioxetine placebo

Intervention Type: DRUG

Other Intervention Names

Lu AA21004; BRINTELLIX; Vortioxetine placebo-matching tablets

Eligibility Criteria

Inclusion Criteria

1. The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).

2. The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.

3. The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.

4. The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits

Exclusion Criteria

1. The subject has one or more of the following conditions:

• Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
• Current diagnosis or 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.
• Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.
• Presence or history of a clinically significant neurological disorder (including epilepsy).
• Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.).
• Any DSM-IV-TR axis II disorder that might compromise the study.

2. The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.

3. The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide within 6 months prior to the Screening Visit.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Manager

Role: STUDY_DIRECTOR

Takeda

Locations

Inzai-shi, Chiba, Japan

Noda, Chiba, Japan

Fukuoka, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Annaka-shi, Gunma, Japan

Fujioka-shi, Gunma, Japan

Takasaki-shi, Gunma, Japan

Hatsukaichi-shi, Hiroshima, Japan

Hiroshima, Hiroshima, Japan

Sapporo, Hokkaido, Japan

Amagasaki-shi, Hyōgo, Japan

Kobe, Hyōgo, Japan

Ibaraki, Ibaraki, Japan

Fujisawa-shi, Kanagawa, Japan

Kawasaki-shi, Kanagawa, Japan

Sagamihara-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Osaka, Kita-ku, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Kurashiki-shi, Okayama-ken, Japan

Osaka, Osaka, Japan

Fukaya-shi, Saitama, Japan

Saitama, Saitama, Japan

Utsunomiya, Tochigi, Japan

Anan-shi, Tokushima, Japan

Tokushisma-shi, Tokushima, Japan

Hachioji-shi, Tokyo, Japan

Katsushika-ku, Tokyo, Japan

Musashino-shi, Tokyo, Japan

Tokyo, Tokyo, Japan

Nanyo-shi, Yamagata, Japan

Countries

Japan

References

Inoue T, Nishimura A, Sasai K, Kitagawa T. Randomized, 8-week, double-blind, placebo-controlled trial of vortioxetine in Japanese adults with major depressive disorder, followed by a 52-week open-label extension trial. Psychiatry Clin Neurosci. 2018 Feb;72(2):103-115. doi: 10.1111/pcn.12623. Epub 2017 Dec 27.

Reference Type: DERIVED

PMID: 29160598 (View on PubMed)

Other Identifiers

U1111-1120-9277

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-111492

Identifier Type: REGISTRY

Identifier Source: secondary_id

LuAA21004/CCT-003

Identifier Type: -

Identifier Source: org_study_id