Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression
NCT ID: NCT03766867
Last Updated: 2019-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2018-12-03
2019-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vortioxetine
Vortioxetine infusion 25 mg
1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days
Vortioxetine tablets 10 mg/day
10 mg, tablets, oral administration once daily
Placebo
Placebo infusion
concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
Placebo tablets
oral administration once daily
Interventions
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Vortioxetine infusion 25 mg
1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days
Vortioxetine tablets 10 mg/day
10 mg, tablets, oral administration once daily
Placebo infusion
concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
Placebo tablets
oral administration once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient has a MADRS total score ≥ 30 at the Screening Visit.
* As part of standard of care treatment, the patient is to be admitted to hospital due to the severity of the depressive symptoms and is willing to remain hospitalized for the duration of the study treatment period.
* The patient has had the current MDE for ≥3 months but less than 12 months.
* The patient has received treatment for the current episode with an SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, sertraline) at an approved dose for at least 6 weeks.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD (BG1004)
Burgas, , Bulgaria
SPH - Kardzhali, EOOD (BG1005)
Kardzhali, , Bulgaria
MHAT "Dr. Hristo Stambolski", EOOD (BG1001)
Kazanlak, , Bulgaria
State Psychiatric Hospital "Sv. Ivan Rilski" (BG1009)
Novi Iskar, , Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD (BG1006)
Pleven, , Bulgaria
MHC - Ruse, EOOD (BG1007)
Rousse, , Bulgaria
State Psychiatric Hospital (BG1008)
Tsarev Brod, , Bulgaria
Mental Health Center-Vratsa EOOD (BG1002)
Vratsa, , Bulgaria
Marienthali Kliinik (EE2001)
Tallinn, , Estonia
Tartu University Hospital (EE2002)
Tartu, , Estonia
Psychoneurological Hospital of Daugavpils (LV3003)
Daugavpils, , Latvia
Riga Centre of Psychiatry and Narcology (LV3002)
Riga, , Latvia
Psychoneurological Hospital of Strenci (LV3001)
Strenči, , Latvia
Countries
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References
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Rancans E, Zambori J, Dalsgaard M, Baayen C, Areberg J, Ettrup A, Florea I. Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study. Int Clin Psychopharmacol. 2020 Nov;35(6):305-312. doi: 10.1097/YIC.0000000000000326.
Other Identifiers
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17915A
Identifier Type: -
Identifier Source: org_study_id
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