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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once
daily (QD), in patients with Major Depressive Disorder.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00735709
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00735709