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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lu AA21004
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Relapse prevention, GAD, Maintenance, Double-blind, Multicentre

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 exclusion criteria may apply.

Sites / Locations

  • AR010
  • AR012
  • AR002
  • AR008
  • AR003
  • AR013
  • AR004
  • AR015
  • AR006
  • AR009
  • AR001
  • CL004
  • CL001
  • CL002
  • CL003
  • CL005
  • CL007
  • CL008
  • CL006
  • CO003
  • CO001
  • CO005
  • CO006
  • CO002
  • CO007
  • CO004
  • CR002
  • CR004
  • CR001
  • CR003
  • EE001
  • EE004
  • EE002
  • FI006
  • FI008
  • FI001
  • FI004
  • FI011
  • FI010
  • FI005
  • FI012
  • FI002
  • FI009
  • FI003
  • FI007
  • FR011
  • FR010
  • FR016
  • FR012
  • FR004
  • FR013
  • FR007
  • FR001
  • FR002
  • FR015
  • FR005
  • HU005
  • HU004
  • HU002
  • HU001
  • HU006
  • HU008
  • PE003
  • PE002
  • RU004
  • RU006
  • RU002
  • RU003
  • RU001
  • ZA006
  • ZA004
  • ZA011
  • ZA012
  • ZA003
  • ZA010
  • ZA007
  • ZA001
  • ZA009
  • ZA002
  • ZA008
  • ZA005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lu AA21004

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to relapse

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2008
Last Updated
June 22, 2015
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00788034
Brief Title
Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder
Official Title
A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Relapse prevention, GAD, Maintenance, Double-blind, Multicentre

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
459 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lu AA21004
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lu AA21004
Other Intervention Name(s)
Vortioxetine
Intervention Description
5 or 10 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Time to relapse
Time Frame
At least 24 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
At least 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
AR010
City
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
AR012
City
Buenos Aires
ZIP/Postal Code
B1900BHE
Country
Argentina
Facility Name
AR002
City
Buenos Aires
ZIP/Postal Code
C1117ABH
Country
Argentina
Facility Name
AR008
City
Buenos Aires
ZIP/Postal Code
C1405BOA
Country
Argentina
Facility Name
AR003
City
Buenos Aires
ZIP/Postal Code
C1425AHQ
Country
Argentina
Facility Name
AR013
City
Buenos Aires
ZIP/Postal Code
C1428AAQ
Country
Argentina
Facility Name
AR004
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
AR015
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
AR006
City
Mendoza
ZIP/Postal Code
M5500BCR
Country
Argentina
Facility Name
AR009
City
Mendoza
ZIP/Postal Code
M5502BKH
Country
Argentina
Facility Name
AR001
City
Santa Fé
ZIP/Postal Code
S2000QJI
Country
Argentina
Facility Name
CL004
City
Antofagasta
Country
Chile
Facility Name
CL001
City
Coquimbo
Country
Chile
Facility Name
CL002
City
Santiago
Country
Chile
Facility Name
CL003
City
Santiago
Country
Chile
Facility Name
CL005
City
Santiago
Country
Chile
Facility Name
CL007
City
Santiago
Country
Chile
Facility Name
CL008
City
Santiago
Country
Chile
Facility Name
CL006
City
Vina del Mar
Country
Chile
Facility Name
CO003
City
Barranquilla
Country
Colombia
Facility Name
CO001
City
Bogotá
Country
Colombia
Facility Name
CO005
City
Bogotá
Country
Colombia
Facility Name
CO006
City
Envigado
Country
Colombia
Facility Name
CO002
City
Medellin
Country
Colombia
Facility Name
CO007
City
Medellin
Country
Colombia
Facility Name
CO004
City
Pareira
Country
Colombia
Facility Name
CR002
City
Escazu
Country
Costa Rica
Facility Name
CR004
City
Guadalupe
Country
Costa Rica
Facility Name
CR001
City
San José
Country
Costa Rica
Facility Name
CR003
City
San Pedro
Country
Costa Rica
Facility Name
EE001
City
Tallinn
ZIP/Postal Code
10613
Country
Estonia
Facility Name
EE004
City
Tallinn
ZIP/Postal Code
13517
Country
Estonia
Facility Name
EE002
City
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
FI006
City
Espoo
ZIP/Postal Code
2650
Country
Finland
Facility Name
FI008
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
FI001
City
Helsinki
ZIP/Postal Code
00530
Country
Finland
Facility Name
FI004
City
Helsinki
ZIP/Postal Code
100
Country
Finland
Facility Name
FI011
City
Helsinki
ZIP/Postal Code
100
Country
Finland
Facility Name
FI010
City
Helsinki
ZIP/Postal Code
99
Country
Finland
Facility Name
FI005
City
Juväskylä
ZIP/Postal Code
40100
Country
Finland
Facility Name
FI012
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
FI002
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
FI009
City
Rauma
ZIP/Postal Code
26100
Country
Finland
Facility Name
FI003
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
FI007
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
FR011
City
Arcachon
ZIP/Postal Code
33120
Country
France
Facility Name
FR010
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
FR016
City
Douai
ZIP/Postal Code
59500
Country
France
Facility Name
FR012
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
FR004
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
FR013
City
Palaiseau
ZIP/Postal Code
91120
Country
France
Facility Name
FR007
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
FR001
City
Saint-André-de-Cubzac
ZIP/Postal Code
33240
Country
France
Facility Name
FR002
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
FR015
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
FR005
City
Toulouse
ZIP/Postal Code
31200
Country
France
Facility Name
HU005
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
HU004
City
Budapest
ZIP/Postal Code
1095
Country
Hungary
Facility Name
HU002
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
HU001
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
HU006
City
Nagykallo
ZIP/Postal Code
4320
Country
Hungary
Facility Name
HU008
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
PE003
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
PE002
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
RU004
City
Chita
ZIP/Postal Code
672090
Country
Russian Federation
Facility Name
RU006
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
RU002
City
St. Petersburg
ZIP/Postal Code
193019
Country
Russian Federation
Facility Name
RU003
City
St. Petersburg
ZIP/Postal Code
193019
Country
Russian Federation
Facility Name
RU001
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
ZA006
City
Bloemfontein
ZIP/Postal Code
9033
Country
South Africa
Facility Name
ZA004
City
Cape Town
ZIP/Postal Code
1
Country
South Africa
Facility Name
ZA011
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
ZA012
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
ZA003
City
Cape Town
ZIP/Postal Code
7140
Country
South Africa
Facility Name
ZA010
City
Cape Town
ZIP/Postal Code
7620
Country
South Africa
Facility Name
ZA007
City
Gauteng
ZIP/Postal Code
157
Country
South Africa
Facility Name
ZA001
City
Gauteng
ZIP/Postal Code
2195
Country
South Africa
Facility Name
ZA009
City
Gauteng
ZIP/Postal Code
7500
Country
South Africa
Facility Name
ZA002
City
Kempton Park
ZIP/Postal Code
1620
Country
South Africa
Facility Name
ZA008
City
KwaZulu Natal
ZIP/Postal Code
3630
Country
South Africa
Facility Name
ZA005
City
Welkom
ZIP/Postal Code
9459
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
22475889
Citation
Baldwin DS, Loft H, Florea I. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):197-207. doi: 10.1097/YIC.0b013e3283530ad7.
Results Reference
result
PubMed Identifier
29081307
Citation
Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30. Erratum In: CNS Spectr. 2019 Apr;24(2):275.
Results Reference
derived

Learn more about this trial

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

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