Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

NCT00735709 | Completed Phase 3 Results

• 3 other identifiers: LuAA21004_3052008-001580-11U1111-1114-0326
• Study Type: interventional
• Target: 560
• Locations: 15 countries
• Sites: 48

Brief Summary

The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.

Conditions

Major Depressive Disorder

Keywords

Depression; Depressive Disorder; Mood Disorder; Mental Disorder; Melancholia, Involutional; Paraphrenia, Involutional; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8

  The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

  Baseline to Week 8

Secondary Outcomes (25)

• Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8

  Baseline to Week 8

• Clinical Global Impression Scale-Global Improvement at Week 8

  Baseline to Week 8

• Percentage of Responders in HAM-D24 Total Score at Week 8

  Baseline and Week 8

• Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20

  Baseline to Week 8

• Percentage of Participants in MADRS Remission at Week 8

  Week 8

Study Arms (4)

Vortioxetine 1 mg

EXPERIMENTAL

Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.

Drug: Vortioxetine

Vortioxetine 5 mg

EXPERIMENTAL

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

Drug: Vortioxetine

Vortioxetine 10 mg

EXPERIMENTAL

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

Drug: Vortioxetine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vortioxetine DRUG

Encapsulated immediate-release vortioxetine tablets

Also known as: Lu AA21004, Brintellix®

Vortioxetine 1 mg; Vortioxetine 10 mg; Vortioxetine 5 mg

Placebo DRUG

Vortioxetine placebo-matching capsules

Placebo

Eligibility Criteria

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

You may qualify if:

• Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
• The reported duration of the current major depressive episode is at least 3 months.
• Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
• A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

You may not qualify if:

• Has 1 or more the following:
• Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
• Current or past 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.
• Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).
• Presence or history of a clinically significant neurological disorder (including epilepsy).
• Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
• Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months.
• Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
• Has a clinically significant unstable illness.
• Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
• Has received electroconvulsive therapy within 6 months prior to Screening.
• Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level \> 1.5 times the upper limit of normal.
• Has a serum creatinine of \> 1.5 × upper limit of normal.
• Has a previous history of cancer that had been in remission for less than 5 years.
• Has thyroid stimulating hormone value outside the normal range.

Sponsors & Collaborators

• Takeda: lead
• H. Lundbeck A/S: collaborator

Study Sites (48)

Unknown Facility

Elizabeth Vale, Australia

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Southport, Australia

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Litoměřice, Czechia

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Lnáře, Czechia

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Prague, Czechia

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Bully-les-Mines, France

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Marseille, France

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Strasbourg, France

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Bochum, Germany

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Chemnitz, Germany

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Dillingen, Germany

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Hüttenberg, Germany

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Leipzig, Germany

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München, Germany

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Nuremberg, Germany

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Osnabrück, Germany

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Rodgau, Germany

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Westerstede, Germany

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Leipaja, Latvia

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Riga, Latvia

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Sigulda, Latvia

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Strenči, Latvia

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Vilnius, Lithuania

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Kuala Lumpur, Malaysia

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Wildervank, Netherlands

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Bialystok, Poland

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Leszno, Poland

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Skórzewo, Poland

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Torun, Poland

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Tuszyn, Poland

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Moscow, Russia

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Saint Petersburg, Russia

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Stavropol, Russia

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Tomsk, Russia

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Veliky Novgorod, Russia

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Durban, South Africa

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Noordheuwel, South Africa

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Pretoria, South Africa

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Bucheon-si, South Korea

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Namdong-gu, South Korea

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Seoul, South Korea

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Lin-Yan District, Taiwan

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Dnipro, Ukraine

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Kharkiv, Ukraine

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Luhansk, Ukraine

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Simferopol, Ukraine

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Bath, United Kingdom

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Bolton, United Kingdom

Location

Related Publications (2)

• Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470.

  PMID: 22901346 BACKGROUND

• McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

  PMID: 27780334 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder; Mood Disorders; Mental Disorders

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director Clinical Science

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 18, 2013
• Results First Posted: December 18, 2013

Record last verified: 2013-10

Locations

NL (1); MY (1); TW (1); UA (4); CZ (3); KR (3); GB (2); RU (5); PL (5); AU (2); LI (1); LA (4); ZA (3); FR (3); DE (10)