Long-Term Extension Study of Lu AA21004 in Participants With Major Depressive Disorder

NCT01395147 | Completed Phase 3

• 3 other identifiers: LuAA21004/OCT-001JapicCTI-111530U1111-1122-3910
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 32

Brief Summary

The purpose of this study is to assess the safety and efficacy of Lu AA21004 in participants with major depressive disorder after completion of an 8-week double-blind treatment period in a preceding study (Lu AA21004/CCT-003; NCT01355081).

Conditions

Major Depressive Disorder

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (6)

• Number of Participants Reporting One or More Treatment-emergent Adverse Events

  Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.

  52 Weeks.

• Number of Participants With Markedly Abnormal Laboratory Values

  The number of participants with any markedly abnormal standard safety laboratory values collected at weeks 4, 12, 24, 36, 48 and 52 relative to baseline.

  Up to week 52.

• Significant Change from Baseline in Body Weight

  Change from baseline in participant's weight measured throughout study.

  Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52.

• Change from Baseline in Vital Signs

  Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).

  52 Weeks.

• Change from Baseline in Electrocardiograms

  Change from baseline in electrocardiograms measured throughout study.

  Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52.

• Clinically Significant Change From Baseline in Physical Examination Findings

  Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).

  52 Weeks.

Secondary Outcomes (3)

• Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at each time point

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52.

• Change from Baseline in the Clinical Global Impression Scale-Severity (CGI-S) score at each time point

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52.

• Change from Baseline in the Clinical Global Impression - Improvement (CGI-I) score at each time point

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52.

Study Arms (1)

Lu AA21004 group

EXPERIMENTAL

Drug: Lu AA21004

Interventions

Lu AA21004 DRUG

Lu AA21004 10 mg, tablets, orally, once daily for 2 weeks; reduced to 5 mg or increased to 20 mg, once daily if necessary according to the responses and symptoms of participants for up to 50 weeks.

Lu AA21004 group

Eligibility Criteria

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

You may qualify if:

• Has completed the double-blind treatment period of the preceding study (CCT-003)
• Signs and dates a written, informed consent form for this study, different from that for the preceding study (CCT-003).
• Has CGI-S score improved at least one point at completion of the 8-week double-blind treatment period compared to the Baseline Visit in the preceding study (CCT-003).
• In the opinion of the investigator, the subject appears to benefit from long-term treatment of Lu AA21004.

You may not qualify if:

• Diagnosed with the following disorder or symptom in the preceding study (CCT-003):
• Any current psychiatric disorder other than MDD as defined in a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).
• Any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.
• 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 this study.
• Is at significant risk of suicide, or had a score ≥5 on Item 10 (suicidal thoughts) of the MADRS or attempted suicides during the preceding study (CCT-003)

Sponsors & Collaborators

• Takeda: lead

Study Sites (32)

Unknown Facility

Inzai-shi, Chiba, Japan

Location

Unknown Facility

Noda, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kitakyushu-shi, Fukuoka, Japan

Location

Unknown Facility

Annaka-shi, Gunma, Japan

Location

Unknown Facility

Fujioka-shi, Gunma, Japan

Location

Unknown Facility

Takasaki-shi, Gunma, Japan

Location

Unknown Facility

Hatsukaichi-shi, Hiroshima, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Amagasaki-shi, Hyōgo, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Ibaraki, Ibaraki, Japan

Location

Unknown Facility

Fujisawa-shi, Kanagawa, Japan

Location

Unknown Facility

Kawasaki-shi, Kanagawa, Japan

Location

Unknown Facility

Sagamihara-shi, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Osaka, Kita-ku, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Kurashiki-shi, Okayama-ken, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Fukaya-shi, Saitama, Japan

Location

Unknown Facility

Saitama, Saitama, Japan

Location

Unknown Facility

Utsunomiya, Tochigi, Japan

Location

Unknown Facility

Anan-shi, Tokushima, Japan

Location

Unknown Facility

Tokushisma-shi, Tokushima, Japan

Location

Unknown Facility

Hachioji-shi, Tokyo, Japan

Location

Unknown Facility

Katsushika-ku, Tokyo, Japan

Location

Unknown Facility

Musashino-shi, Tokyo, Japan

Location

Unknown Facility

Tokyo, Tokyo, Japan

Location

Unknown Facility

Nanyo-shi, Yamagata, Japan

Location

Related Publications (1)

• 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.

  PMID: 29160598 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

Study Officials

• Senior Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 15, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

JP (32)