Clinical Trials Logo
  1. Home
  2. Generalized Anxiety Disorder
  3. NCT00744627

Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.

Generalized Anxiety Disorder Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of a Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.

Clinical Trial Description

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.

The study enrolled 301 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

- Vortioxetine 5 mg

- Placebo (dummy inactive pill) - 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 Europe. The overall time to participate in this study was up to 13 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 NCT00744627
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date July 2009
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03420456 - Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Withdrawn NCT02382224 - Worry Exposure for Generalized Anxiety Disorder N/A
Completed NCT02306356 - Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting N/A
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Completed NCT01958788 - Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder N/A
Completed NCT01681329 - Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder N/A
Completed NCT01342120 - PHARMO Institute Seroquel Safety Study N/A
Completed NCT01201967 - A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients Phase 4
Completed NCT01337713 - Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD) N/A
Completed NCT00961298 - An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder Phase 4
Completed NCT01971203 - Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat N/A
Completed NCT01203293 - Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector Phase 1
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00525226 - Evaluating the Effects of Stress in Pregnancy N/A
Completed NCT00537615 - An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers Phase 1
Completed NCT00515242 - Therapeutic Massage for Generalized Anxiety Disorder Phase 1/Phase 2
Completed NCT00620776 - Combined Treatment for Generalized Anxiety Disorder (GAD) Phase 2
Completed NCT00368745 - Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use. Phase 3