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)

RU001; 🇷🇺 Tomsk, Russian Federation

ZA012; 🇿🇦 Cape Town, South Africa

ZA010; 🇿🇦 Cape Town, South Africa

FR005; 🇫🇷 Toulouse, France

HU005; 🇭🇺 Budapest, Hungary

ZA003; 🇿🇦 Cape Town, South Africa

RU003; 🇷🇺 St. Petersburg, Russian Federation

ZA004; 🇿🇦 Cape Town, South Africa

ZA006; 🇿🇦 Bloemfontein, South Africa

ZA007; 🇿🇦 Gauteng, South Africa

FR001; 🇫🇷 Saint-André-de-Cubzac, France

HU004; 🇭🇺 Budapest, Hungary

RU004; 🇷🇺 Chita, Russian Federation

PE003; 🇵🇪 Lima, Peru

HU006; 🇭🇺 Nagykallo, Hungary

FR002; 🇫🇷 Strasbourg, France

HU008; 🇭🇺 Sopron, Hungary

FR015; 🇫🇷 Toulouse, France

PE002; 🇵🇪 Lima, Peru

RU006; 🇷🇺 St. Petersburg, Russian Federation

HU001; 🇭🇺 Gyula, Hungary

EE001; 🇪🇪 Tallinn, Estonia

AR008; 🇦🇷 Buenos Aires, Argentina

FR010; 🇫🇷 Caen, France

AR012; 🇦🇷 Buenos Aires, Argentina

AR004; 🇦🇷 Cordoba, Argentina

AR015; 🇦🇷 La Plata, Argentina

AR013; 🇦🇷 Buenos Aires, Argentina

AR002; 🇦🇷 Buenos Aires, Argentina

AR009; 🇦🇷 Mendoza, Argentina

CO005; 🇨🇴 Bogotá, Colombia

CO006; 🇨🇴 Envigado, Colombia

CO007; 🇨🇴 Medellin, Colombia

FI006; 🇫🇮 Espoo, Finland

CL002; 🇨🇱 Santiago, Chile

CL006; 🇨🇱 Vina del Mar, Chile

FR011; 🇫🇷 Arcachon, France

CO003; 🇨🇴 Barranquilla, Colombia

CO001; 🇨🇴 Bogotá, Colombia

CR003; 🇨🇷 San Pedro, Costa Rica

RU002; 🇷🇺 St. Petersburg, Russian Federation

ZA009; 🇿🇦 Gauteng, South Africa

ZA011; 🇿🇦 Cape Town, South Africa

FR013; 🇫🇷 Palaiseau, France

EE004; 🇪🇪 Tallinn, Estonia

FR016; 🇫🇷 Douai, France

FI005; 🇫🇮 Juväskylä, Finland

FI002; 🇫🇮 Oulu, Finland

FR004; 🇫🇷 Nîmes, France

FR012; 🇫🇷 Nantes, France

FR007; 🇫🇷 Rennes, France

ZA001; 🇿🇦 Gauteng, South Africa

ZA002; 🇿🇦 Kempton Park, South Africa

ZA008; 🇿🇦 KwaZulu Natal, South Africa

ZA005; 🇿🇦 Welkom, South Africa

AR010; 🇦🇷 Buenos Aires, Argentina

AR001; 🇦🇷 Santa Fé, Argentina

AR003; 🇦🇷 Buenos Aires, Argentina

AR006; 🇦🇷 Mendoza, Argentina

HU002; 🇭🇺 Budapest, Hungary

CR001; 🇨🇷 San José, Costa Rica

FI004; 🇫🇮 Helsinki, Finland

FI012; 🇫🇮 Kuopio, Finland

CL004; 🇨🇱 Antofagasta, Chile

CL005; 🇨🇱 Santiago, Chile

CR002; 🇨🇷 Escazu, Costa Rica

CO002; 🇨🇴 Medellin, Colombia

EE002; 🇪🇪 Tartu, Estonia

FI011; 🇫🇮 Helsinki, Finland

CL007; 🇨🇱 Santiago, Chile

FI009; 🇫🇮 Rauma, Finland

FI007; 🇫🇮 Turku, Finland

CL001; 🇨🇱 Coquimbo, Chile

CL003; 🇨🇱 Santiago, Chile

CL008; 🇨🇱 Santiago, Chile

CO004; 🇨🇴 Pareira, Colombia

CR004; 🇨🇷 Guadalupe, Costa Rica

FI008; 🇫🇮 Helsinki, Finland

FI001; 🇫🇮 Helsinki, Finland

FI010; 🇫🇮 Helsinki, Finland

FI003; 🇫🇮 Turku, Finland