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

NCT ID: NCT00735709

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-08-31

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.

Detailed Description

The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 560 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

• Vortioxetine 1 mg
• Vortioxetine 5 mg
• Vortioxetine 10 mg
• Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-centre trial was conducted in Europe, Asia, Australia, and South Africa. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Conditions

Major Depressive Disorder

Keywords

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

Study Design

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

Study Groups

Vortioxetine 1 mg

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

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Encapsulated immediate-release vortioxetine tablets

Vortioxetine 5 mg

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

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Encapsulated immediate-release vortioxetine tablets

Vortioxetine 10 mg

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

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Encapsulated immediate-release vortioxetine tablets

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vortioxetine placebo-matching capsules

Interventions

Vortioxetine

Encapsulated immediate-release vortioxetine tablets

Intervention Type: DRUG

Placebo

Vortioxetine placebo-matching capsules

Intervention Type: DRUG

Other Intervention Names

Lu AA21004; Brintellix®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Has an abnormal electrocardiogram.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Elizabeth Vale, , Australia

Southport, , Australia

Litoměřice, , Czechia

Lnáře, , Czechia

Prague, , Czechia

Bully-les-Mines, , France

Marseille, , France

Strasbourg, , France

Bochum, , Germany

Chemnitz, , Germany

Dillingen, , Germany

Hüttenberg, , Germany

Leipzig, , Germany

München, , Germany

Nuremberg, , Germany

Osnabrück, , Germany

Rodgau, , Germany

Westerstede, , Germany

Leipaja, , Latvia

Riga, , Latvia

Sigulda, , Latvia

Strenči, , Latvia

Vilnius, , Lithuania

Kuala Lumpur, , Malaysia

Wildervank, , Netherlands

Bialystok, , Poland

Leszno, , Poland

Skórzewo, , Poland

Torun, , Poland

Tuszyn, , Poland

Moscow, , Russia

Saint Petersburg, , Russia

Stavropol, , Russia

Tomsk, , Russia

Veliky Novgorod, , Russia

Durban, , South Africa

Noordheuwel, , South Africa

Pretoria, , South Africa

Bucheon-si, , South Korea

Namdong-gu, , South Korea

Seoul, , South Korea

Lin-Yan District, , Taiwan

Dnipro, , Ukraine

Kharkiv, , Ukraine

Luhansk, , Ukraine

Simferopol, , Ukraine

Bath, , United Kingdom

Bolton, , United Kingdom

Countries

Croatia; Serbia; Australia; Czechia; France; Germany; Latvia; Lithuania; Malaysia; Netherlands; Poland; Russia; South Africa; South Korea; Taiwan; Ukraine; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 22901346 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27780334 (View on PubMed)

Other Identifiers

2008-001580-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1114-0326

Identifier Type: REGISTRY

Identifier Source: secondary_id

LuAA21004_305

Identifier Type: -

Identifier Source: org_study_id