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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00735709




Registration number
NCT00735709
Ethics application status
Date submitted
14/08/2008
Date registered
15/08/2008
Date last updated
18/12/2013

Titles & IDs
Public title
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Scientific title
A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Secondary ID [1] 0 0
2008-001580-11
Secondary ID [2] 0 0
LuAA21004_305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vortioxetine
Treatment: Drugs - Placebo

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

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

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

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


Treatment: Drugs: Vortioxetine
Encapsulated immediate-release vortioxetine tablets

Treatment: Drugs: Placebo
Vortioxetine placebo-matching capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8
Timepoint [1] 0 0
Baseline to Week 8
Secondary outcome [1] 0 0
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
Timepoint [1] 0 0
Baseline to Week 8
Secondary outcome [2] 0 0
Clinical Global Impression Scale-Global Improvement at Week 8
Timepoint [2] 0 0
Baseline to Week 8
Secondary outcome [3] 0 0
Percentage of Responders in HAM-D24 Total Score at Week 8
Timepoint [3] 0 0
Baseline and Week 8
Secondary outcome [4] 0 0
Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score =20
Timepoint [4] 0 0
Baseline to Week 8
Secondary outcome [5] 0 0
Percentage of Participants in MADRS Remission at Week 8
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
Timepoint [6] 0 0
Baseline and Weeks 1, 2, 4 and 6
Secondary outcome [7] 0 0
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed
Timepoint [7] 0 0
Baseline and Weeks 1, 2 and 6
Secondary outcome [8] 0 0
Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
Timepoint [8] 0 0
Baseline and Weeks 1, 2, 4 and 6
Secondary outcome [9] 0 0
Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed
Timepoint [9] 0 0
Baseline and Weeks 1, 2, 4 and 6
Secondary outcome [10] 0 0
Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score =20
Timepoint [10] 0 0
Baseline and Weeks 1, 2, 4 and 6
Secondary outcome [11] 0 0
Percentage of Participants in MADRS Remission at Other Weeks Assessed
Timepoint [11] 0 0
Weeks 1, 2, 4 and 6
Secondary outcome [12] 0 0
Percentage of Participants With a Sustained Response in HAM-D24 Total Score
Timepoint [12] 0 0
From Baseline through Week 8
Secondary outcome [13] 0 0
Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week
Timepoint [13] 0 0
Baseline and Weeks 1, 2, 4, 6, and 8
Secondary outcome [14] 0 0
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed
Timepoint [14] 0 0
Baseline and Weeks 1, 2, 4, 6, and 8
Secondary outcome [15] 0 0
Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed
Timepoint [15] 0 0
Baseline and Weeks 1, 2, 4, 6, and 8
Secondary outcome [16] 0 0
Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed
Timepoint [16] 0 0
Baseline and Weeks 1, 4, and 8
Secondary outcome [17] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed
Timepoint [17] 0 0
Baseline and Weeks 2, 4 and 8
Secondary outcome [18] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed
Timepoint [18] 0 0
Baseline and Weeks 2, 4 and 8
Secondary outcome [19] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed
Timepoint [19] 0 0
Baseline and Weeks 2, 4 and 8
Secondary outcome [20] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed
Timepoint [20] 0 0
Baseline and Weeks 2, 4 and 8
Secondary outcome [21] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed
Timepoint [21] 0 0
Baseline and Weeks 2, 4 and 8
Secondary outcome [22] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed
Timepoint [22] 0 0
Baseline and Weeks 2 and 4
Secondary outcome [23] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed
Timepoint [23] 0 0
Baseline and Weeks 2, 4 and 8
Secondary outcome [24] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed
Timepoint [24] 0 0
Baseline and Weeks 2, 4 and 8
Secondary outcome [25] 0 0
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.
Timepoint [25] 0 0
Baseline and Week 8

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
Accrual to date
Final
560
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Elizabeth Vale
Recruitment hospital [2] 0 0
- Southport
Recruitment postcode(s) [1] 0 0
- Elizabeth Vale
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Litomerice
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Lnare
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Prague
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Praha
Country [5] 0 0
France
State/province [5] 0 0
Bully les Mines
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Strasbourg
Country [8] 0 0
Germany
State/province [8] 0 0
Bochum
Country [9] 0 0
Germany
State/province [9] 0 0
Chemnitz
Country [10] 0 0
Germany
State/province [10] 0 0
Dillingen
Country [11] 0 0
Germany
State/province [11] 0 0
Huettenberg
Country [12] 0 0
Germany
State/province [12] 0 0
Leipzig
Country [13] 0 0
Germany
State/province [13] 0 0
Munchen
Country [14] 0 0
Germany
State/province [14] 0 0
München
Country [15] 0 0
Germany
State/province [15] 0 0
Nuernberg
Country [16] 0 0
Germany
State/province [16] 0 0
Osnabrueck
Country [17] 0 0
Germany
State/province [17] 0 0
Rodgau
Country [18] 0 0
Germany
State/province [18] 0 0
Westerstede
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Bucheon-si
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Namdong-gu
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Latvia
State/province [22] 0 0
Leipaja
Country [23] 0 0
Latvia
State/province [23] 0 0
Riga
Country [24] 0 0
Latvia
State/province [24] 0 0
Sigulda
Country [25] 0 0
Latvia
State/province [25] 0 0
Strenci
Country [26] 0 0
Lithuania
State/province [26] 0 0
Vilnius
Country [27] 0 0
Malaysia
State/province [27] 0 0
Kuala Lumpur
Country [28] 0 0
Netherlands
State/province [28] 0 0
Wildervank
Country [29] 0 0
Poland
State/province [29] 0 0
Bialystok
Country [30] 0 0
Poland
State/province [30] 0 0
Leszno
Country [31] 0 0
Poland
State/province [31] 0 0
Skórzewo
Country [32] 0 0
Poland
State/province [32] 0 0
Torun
Country [33] 0 0
Poland
State/province [33] 0 0
Tuszyn
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Moscow
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Novgorod
Country [36] 0 0
Russian Federation
State/province [36] 0 0
St. Petersburg
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Stavropol
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Tomsk
Country [39] 0 0
South Africa
State/province [39] 0 0
Durban
Country [40] 0 0
South Africa
State/province [40] 0 0
Noordheuwel
Country [41] 0 0
South Africa
State/province [41] 0 0
Pretoria
Country [42] 0 0
Taiwan
State/province [42] 0 0
Lin-Yan District
Country [43] 0 0
Ukraine
State/province [43] 0 0
Dnepropetrovsk
Country [44] 0 0
Ukraine
State/province [44] 0 0
Kharkiv
Country [45] 0 0
Ukraine
State/province [45] 0 0
Lugansk
Country [46] 0 0
Ukraine
State/province [46] 0 0
Simferopol
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Bath
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Bolton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
H. Lundbeck A/S
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00735709