Clinical Trials Logo
  1. Home
  2. Depressive Disorder, Major
  3. NCT01179516

Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

Official title:
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 15 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

Clinical Trial Summary

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

Clinical Trial 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 dosages of vortioxetine.

The study enrolled 469 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups—which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

- Vortioxetine 10 mg

- Vortioxetine 15 mg

- Placebo (dummy inactive capsule) - 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 the United States. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01179516
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date August 2010
Completion date June 2012
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05988333 - Psychoeducational Intervention for Families With a Member Affected by Major Depression N/A
Completed NCT02919501 - Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder Phase 2
Completed NCT00976560 - Clinical Study to Test a New Drug to Treat Major Depression Phase 2
Recruiting NCT05518149 - A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) Phase 3
Not yet recruiting NCT06303076 - Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial Phase 4
Not yet recruiting NCT05901571 - Acupuncture and Escitalopram for Treating Major Depression Clinical Study N/A
Suspended NCT02546024 - Predictors of Treatment Response in Late-onset Major Depressive Disorder N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01583400 - Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial N/A
Completed NCT01152996 - Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study Phase 3
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00369343 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women Phase 3
Completed NCT00366652 - Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects Phase 3
Completed NCT00384033 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder Phase 3
Completed NCT00149643 - Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence Phase 2
Completed NCT00316160 - Sexual Functioning Study With Antidepressants Phase 4