Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Takeda
Study ID
NCT00672620
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Vortioxetine — DRUG
    Encapsulated vortioxetine immediate-release tablets
  • Duloxetine — DRUG
    Duloxetine capsules
  • Placebo — DRUG
    Placebo-matching capsules

Study Details

The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

Key Dates

Start date
Apr 30, 2008
Status verified
Oct 2013
Primary completion
Nov 30, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
611 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vortioxetine 2.5 mg
    Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
  • Experimental: Vortioxetine 5 mg
    Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
  • Active Comparator: Duloxetine 60 mg
    Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsules, orally, once daily for 1 week after the treatment period.
  • Placebo Comparator: Placebo
    Placebo-matching capsules, orally, once daily for up to 9 weeks.

Primary Outcome Measure

Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8 [ Time Frame: Baseline and Week 8 ]

Locations (38)

FacilityCityStateZIPSite coordinators
-Beverly HillsCalifornia--
-IrvineCalifornia--
-Santa AnaCalifornia--
-TorranceCalifornia--
-UplandCalifornia--
-BradentonFlorida--
-Coral SpringsFlorida--
-Fort Walton BeachFlorida--
-GainesvilleFlorida--
-JacksonvilleFlorida--
-MaitlandFlorida--
-OrlandoFlorida--
-South MiamiFlorida--
-West Palm BeachFlorida--
-AtlantaGeorgia--
-SmyrnaGeorgia--
-ChicagoIllinois--
-LibertyvilleIllinois--
-Oak BrookIllinois--
-Prairie VillageKansas--
-OwensboroKentucky--
-BaltimoreMaryland--
-PittsfieldMassachusetts--
-WorcesterMassachusetts--
-FlowoodMississippi--
-New YorkNew York--
-OleanNew York--
-BeachwoodOhio--
-ToledoOhio--
-Oklahoma CityOklahoma--
-AllenportPennsylvania--
-LancasterPennsylvania--
-MemphisTennessee--
-AustinTexas--
-San AntonioTexas--
-Salt Lake CityUtah--
-SeattleWashington--
-MilwaukeeWisconsin--

Find similar trials in Beverly Hills, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health

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