A Phase 3 Study of Lu AA21004 in Patients With Major Depressive Disorder

NCT02389816 | Completed Phase 3 Results

• 3 other identifiers: LuAA21004/CCT-004U1111-1167-1520JapicCTI-152831
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 47

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.

Conditions

Major Depressive Disorder

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (8)

• 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 Clinical Global Impressions-Severity (CGI-S) Score to Week 8 (LOCF)

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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Vortioxetine 10 mg

EXPERIMENTAL

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

Drug: Vortioxetine

Vortioxetine 20 mg

EXPERIMENTAL

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

Drug: Vortioxetine

Interventions

Placebo DRUG

Placebo tablets

Placebo

Vortioxetine DRUG

Vortioxetine tablets

Also known as: Lu AA21004

Vortioxetine 10 mg; Vortioxetine 20 mg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• In the opinion of the investigator or sub-investigator, the participant has experienced significant number of major depressive episodes in the past, and is suspected of disease other than MDD.
• In the opinion of the investigator or sub-investigator, the participant has experienced the first major depressive episode at his/her young age, and is suspected of disease other than MDD.
• The participant has a MADRS total score at the start of double-blind treatment period that has improved or aggravated by 25% or more from the score at the start of placebo lead-in period.
• The participant is significantly non-compliant with the study drug in the placebo lead-in period; e.g., not taking the study drug for 6 or more consecutive days.
• The participant has received electroconvulsive therapy, vagus nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the screening period, or plans to initiate such therapy during the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (47)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Nagareyama, Chiba, Japan

Location

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Noda, Chiba, Japan

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Iizuka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Kōriyama, Fukushima, Japan

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Shirakawa, Fukushima, Japan

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Sapporo, Hokkaido, Japan

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Ashiya, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokosuka, Kanagawa, Japan

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Kurashiki, Okayama-ken, Japan

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Kadoma, Osaka, Japan

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Kita-ku, Osaka, Japan

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Sakai, Osaka, Japan

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Sayama, Osaka, Japan

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Karatsu, Saga-ken, Japan

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Kawagoe, Saitama, Japan

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Kusatsu, Shiga, Japan

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Anan, Tokushima, Japan

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Arakawa-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Katsushika-ku, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Meguro-ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Musashino, Tokyo, Japan

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Nakano-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Shibuya-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Suginami-ku, Tokyo, Japan

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Taito-ku, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Kofu, Yamanashi, Japan

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Fukuoka, Japan

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Hiroshima, Japan

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Kumamoto, Japan

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Unknown Facility

Okayama, Japan

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Unknown Facility

Saitama, Japan

Location

Related Publications (3)

• Watanabe K, Fujimoto S, Marumoto T, Kitagawa T, Ishida K, Nakajima T, Moriguchi Y, Fujikawa K, Inoue T. Therapeutic Potential of Vortioxetine for Anhedonia-Like Symptoms in Depression: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan. Neuropsychiatr Dis Treat. 2022 Feb 19;18:363-373. doi: 10.2147/NDT.S340281. eCollection 2022.

  PMID: 35221687 DERIVED

• Inoue T, Fujimoto S, Marumoto T, Kitagawa T, Ishida K, Nakajima T, Moriguchi Y, Fujikawa K, Watanabe K. Therapeutic Potential of Vortioxetine for Anxious Depression: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan. Neuropsychiatr Dis Treat. 2021 Dec 21;17:3781-3790. doi: 10.2147/NDT.S335028. eCollection 2021.

  PMID: 34992372 DERIVED

• Inoue T, Fujimoto S, Marumoto T, Kitagawa T, Ishida K, Nakajima T, Moriguchi Y, Fujikawa K, Watanabe K. Early Improvement with Vortioxetine Predicts Response and Remission: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan. Neuropsychiatr Dis Treat. 2021 Dec 18;17:3735-3741. doi: 10.2147/NDT.S340309. eCollection 2021.

  PMID: 34955641 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: April 10, 2015
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: March 24, 2021
• Results First Posted: June 26, 2019

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (47)