Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder

A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00788034

Enrollment

459

Registered

2008-11-10

Start date

2008-10-31

Completion date

2010-07-31

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Keywords

Relapse prevention, GAD, Maintenance, Double-blind, Multicentre

Brief summary

The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.

Detailed description

GAD is a common and disabling mental disorder associated with substantial medical and psychiatric comorbidity and occupational impairment. It is characterized by inappropriate or excessive anxiety and worrying that persists over time for more than six months. Common features include apprehension, with worries about future misfortune; inner tension and difficulty in concentrating; motor tension, with restlessness, tremor and headache; and autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort. GAD is typically a chronic disorder with a high relapse rate and therefore requires effective long-term treatment. Long-term studies are necessary to demonstrate that the short-term effect is maintained.

Interventions

DRUGLu AA21004

5 or 10 mg/day

DRUGPlacebo

Once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

The patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02). * The patient has a HAM-A total score \>=20 at screening and baseline visits * The patient has a HAM-A score \>=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits * The patient has a MADRS total score \<=16 at screening and baseline visits

Exclusion criteria

* Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI) * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR * Women of childbearing potential not using effective contraception Other protocol-defined inclusion and

Design outcomes

Primary

Measure	Time frame
Time to relapse	At least 24 weeks

Secondary

Measure	Time frame
Relapse rates, Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), MOS SF-36, Sheehan Disability Scale (SDS), Adverse events, Clinical laboratory tests, Vital signs, ECG	At least 24 weeks

Countries

Argentina, Chile, Colombia, Costa Rica, Estonia, Finland, France, Hungary, Peru, Russia, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026