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

Phase 3

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: Lu AA21004; Drug: Placebo

• Registration Number: NCT00788034
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2012-12
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

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 exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AA21004	Lu AA21004	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to relapse	At least 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (81)

AR010; 🇦🇷 Buenos Aires, Argentina

AR012; 🇦🇷 Buenos Aires, Argentina

AR002; 🇦🇷 Buenos Aires, Argentina

AR008; 🇦🇷 Buenos Aires, Argentina

AR003; 🇦🇷 Buenos Aires, Argentina

AR013; 🇦🇷 Buenos Aires, Argentina

AR004; 🇦🇷 Cordoba, Argentina

AR015; 🇦🇷 La Plata, Argentina

AR006; 🇦🇷 Mendoza, Argentina

AR009; 🇦🇷 Mendoza, Argentina

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