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

NCT ID: NCT01255787

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-04-30

Brief Summary

The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants 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 doses of vortioxetine.

The study enrolled 600 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 5 mg
• Vortioxetine 10 mg
• Vortioxetine 20 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-center trial was conducted in 14 countries in Europe and Asia. The overall time to participate in this study was up to 13 weeks. Participants made weekly visits to the clinic during the first 2 weeks of the 8-week treatment period and then every 2 weeks up to the end of the 8-week treatment period. Participants who completed the 8-week treatment period entered a 2-week discontinuation period to assess potential discontinuation symptoms 1 and 2 weeks after the end of the 8-week treatment period. A safety follow-up contact (visit or phone call) was made 4 weeks after completion of the 8-week double-blind treatment period (2 weeks after the end of the 2-week discontinuation period).

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder; Depression; Melancholia; Drug Therapy

Study Design

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

Study Groups

Placebo

Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Vortioxetine placebo-matching tablets

Vortioxetine 5 mg

Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Vortioxetine tablets

Placebo

Intervention Type: DRUG

Vortioxetine placebo-matching tablets

Vortioxetine 10 mg

Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Vortioxetine tablets

Placebo

Intervention Type: DRUG

Vortioxetine placebo-matching tablets

Vortioxetine 20 mg

Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Vortioxetine tablets

Placebo

Intervention Type: DRUG

Vortioxetine placebo-matching tablets

Interventions

Vortioxetine

Vortioxetine tablets

Intervention Type: DRUG

Placebo

Vortioxetine placebo-matching tablets

Intervention Type: DRUG

Other Intervention Names

Lu AA21004; Brintellix®

Eligibility Criteria

Inclusion Criteria

1. Suffers from Major Depressive Disorder as the primary diagnosis according to 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. Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.

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

Exclusion Criteria

1. Has one or more of the following conditions:

• Any current psychiatric disorder other than Major Depressive Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR; assessed by the Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless fulfilling 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. Participant with confirmed positive urine drug screens (except prescribed medications or a medication that does not constitute drug abuse) will be excluded.
• 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 participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.

3. Has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit.

4. Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Split, Croatia, Croatia

Zagreb, Croatia, Croatia

Helsinki, Finland, Finland

Kuopio, Finland, Finland

Oulu, Finland, Finland

Tampere, Finland, Finland

Berlin, Germany, Germany

Bochum, Germany, Germany

Chemnitz, Germany, Germany

Hanover, Germany, Germany

Leipzig, Germany, Germany

München, Germany, Germany

Nuremberg, Germany, Germany

Schwerin, Germany, Germany

Westerstede, Germany, Germany

Wiesbaden, Germany, Germany

Hong Kong, Hong Kong, Hong Kong

Hyderabad, Andhra Pradesh, India

Ahmedabad, Gujarat, India

Kanpur, Uttar Pradesh, India

Lucknow, Uttar Pradesh, India

Varanasi, Uttar Pradesh, India

Tokoname-shi, Aichi-ken, Japan

Fukuoka, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Omuta-shi, Fukuoka, Japan

Shirakawa-shi, Fukushima, Japan

Sapporo, Hokkaido, Japan

Yokohama, Kanagawa, Japan

Kumamoto, Kumamoto, Japan

Tokyo, Tokyo, Japan

Liepāja, Latvia, Latvia

Riga, Latvia, Latvia

Sigulda, Latvia, Latvia

Johor Bahru, Malaysia, Malaysia

Kuala Lumpur, Malaysia, Malaysia

Makati City, NCR, Philippines

Mandaluyong, NCR, Philippines

Manila, NCR, Philippines

Quezon City, NCR, Philippines

Bialystok, Poland, Poland

Gorlice, Poland, Poland

Leszno, Poland, Poland

Torun, Poland, Poland

Żuromin, Poland, Poland

Iași, Lasi, Romania

Târgu Mureş, Mureș County, Romania

Bucharest, Romania, Romania

Nizhny Novgorod, Russia, Russia

Rostov-on-Don, Russia, Russia

Saint Petersburg, Russia, Russia

Smolensk, Russia, Russia

Stavropol, Russia, Russia

Yekaterinburg, Russia, Russia

Belgrade, Serbia, Serbia

Kragujevac, Serbia, Serbia

Senta, Serbia, Serbia

Sungnam-si, Gyeonggi-do, South Korea

Incheon, Korea, South Korea

Seoul, Korea, South Korea

Yangsan, Korea, South Korea

Changhua, Taiwan, Taiwan

Kaohsiung City, Taiwan, Taiwan

Taipei, Taiwan, Taiwan

Taoyuan Hsien, Taiwan, Taiwan

Chernigiv Region, Ukraine, Ukraine

Dnipropetrovsk, Ukraine, Ukraine

Kharkiv, Ukraine, Ukraine

Kiev, Ukraine, Ukraine

Luhansk, Ukraine, Ukraine

Countries

Croatia; Finland; Germany; Hong Kong; India; Japan; Latvia; Malaysia; Philippines; Poland; Romania; Russia; Serbia; South Korea; Taiwan; Ukraine

References

Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.

Reference Type: DERIVED

PMID: 36708956 (View on PubMed)

Nishimura A, Aritomi Y, Sasai K, Kitagawa T, Mahableshwarkar AR. Randomized, double-blind, placebo-controlled 8-week trial of the efficacy, safety, and tolerability of 5, 10, and 20 mg/day vortioxetine in adults with major depressive disorder. Psychiatry Clin Neurosci. 2018 Feb;72(2):64-72. doi: 10.1111/pcn.12565. Epub 2017 Oct 3.

Reference Type: DERIVED

PMID: 28858412 (View on PubMed)

Other Identifiers

2010-022257-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1117-6595

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-101344

Identifier Type: REGISTRY

Identifier Source: secondary_id

CTRI/2011/08/001963

Identifier Type: REGISTRY

Identifier Source: secondary_id

LuAA21004/CCT-002

Identifier Type: -

Identifier Source: org_study_id