PLATINUM: Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00314210
Collaborator
(none)
575
114
17
5
0.3
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD).
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period
Study Start Date
:
Mar 1, 2006
Actual Study Completion Date
:
Aug 1, 2007
Outcome Measures
Primary Outcome Measures
- Time from randomisation to occurrence of an anxiety event []
Secondary Outcome Measures
- Occurrence of an anxiety event []
- Change from randomisation in HAM-A/CGI-S scores []
- In HAM-A psychic/somatic anxiety factor scores []
- In MADRS total score and in MADRS item 10 score (suicidal thought) []
- Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.
Exclusion Criteria:
- Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Mesa | Arizona | United States | |
| 2 | Research Site | Peoria | Arizona | United States | |
| 3 | Research Site | Phoenix | Arizona | United States | |
| 4 | Research Site | Fresno | California | United States | |
| 5 | Research Site | La Mesa | California | United States | |
| 6 | Research Site | Oceanside | California | United States | |
| 7 | Research Site | Redlands | California | United States | |
| 8 | Research Site | Coral Springs | Florida | United States | |
| 9 | Research Site | Deland | Florida | United States | |
| 10 | Research Site | Ft Myers | Florida | United States | |
| 11 | Research Site | Gainsville | Florida | United States | |
| 12 | Research Site | Hialeah | Florida | United States | |
| 13 | Research Site | Jacksonville | Florida | United States | |
| 14 | Research Site | North Miami | Florida | United States | |
| 15 | Research Site | Orlando | Florida | United States | |
| 16 | Research Site | St Petersberg | Florida | United States | |
| 17 | Research Site | Atlanta | Georgia | United States | |
| 18 | Research Site | Columbus | Georgia | United States | |
| 19 | Research Site | Marietta | Georgia | United States | |
| 20 | Research Site | Roswell | Georgia | United States | |
| 21 | Research Site | Coeur D'alene | Idaho | United States | |
| 22 | Research Site | Hoffman Estates | Illinois | United States | |
| 23 | Research Site | Libertyville | Illinois | United States | |
| 24 | Research Site | Indianapolis | Indiana | United States | |
| 25 | Research Site | Lafayette | Indiana | United States | |
| 26 | Research Site | Valparaiso | Indiana | United States | |
| 27 | Research Site | Prairie Village | Kansas | United States | |
| 28 | Research Site | Owensboro | Kentucky | United States | |
| 29 | Research Site | Paducah | Kentucky | United States | |
| 30 | Research Site | Shreveport | Louisiana | United States | |
| 31 | Research Site | Glen Burnie | Maryland | United States | |
| 32 | Research Site | Boston | Massachusetts | United States | |
| 33 | Research Site | Cambridge | Massachusetts | United States | |
| 34 | Research Site | Pittsfield | Massachusetts | United States | |
| 35 | Research Site | St Charles | Missouri | United States | |
| 36 | Research Site | Piscataway | New Jersey | United States | |
| 37 | Research Site | Bronx | New York | United States | |
| 38 | Research Site | Cedarhurst | New York | United States | |
| 39 | Research Site | New York | New York | United States | |
| 40 | Research Site | Rochester | New York | United States | |
| 41 | Research Site | Avon Lake | Ohio | United States | |
| 42 | Research Site | Beechwood | Ohio | United States | |
| 43 | Research Site | Cincinnati | Ohio | United States | |
| 44 | Research SIte | Middleburg Heights | Ohio | United States | |
| 45 | Research Site | Toledo | Ohio | United States | |
| 46 | Research Site | Oklahoma City | Oklahoma | United States | |
| 47 | Research Site | Allentown | Pennsylvania | United States | |
| 48 | Research Site | Havertown | Pennsylvania | United States | |
| 49 | Research Site | Pittsburgh | Pennsylvania | United States | |
| 50 | Research Site | N. Charleston | South Carolina | United States | |
| 51 | Research Site | Memphis | Tennessee | United States | |
| 52 | Research Site | Desoto | Texas | United States | |
| 53 | Research Site | San Antonio | Texas | United States | |
| 54 | Research Site | Wichita Falls | Texas | United States | |
| 55 | Research Site | Midvale | Utah | United States | |
| 56 | Research Site | Richmond | Virginia | United States | |
| 57 | Research Site | Brisbane | Queensland | Australia | |
| 58 | Research Site | Everton Park | Queensland | Australia | |
| 59 | Research Site | West Burleigh | Queensland | Australia | |
| 60 | Research Site | Malvern | Victoria | Australia | |
| 61 | Research Site | Prahran | Victoria | Australia | |
| 62 | Research Site | Edmonton | Alberta | Canada | |
| 63 | Research Site | Bathurst | New Brunswick | Canada | |
| 64 | Research Site | Hamilton | Ontario | Canada | |
| 65 | Research Site | Kingston | Ontario | Canada | |
| 66 | Research Site | Orleans | Ontario | Canada | |
| 67 | Research Site | Toronto | Ontario | Canada | |
| 68 | Research Site | Waterloo | Ontario | Canada | |
| 69 | Research Site | Gatineau | Quebec | Canada | |
| 70 | Research Site | Montreal | Quebec | Canada | |
| 71 | Research Site | Helsinki | Finland | ||
| 72 | Research Site | Joensuu | Finland | ||
| 73 | Research Site | Kuopio | Finland | ||
| 74 | Research Site | Oulu | Finland | ||
| 75 | Research Site | Pori | Finland | ||
| 76 | Research Site | Seinajoki | Finland | ||
| 77 | Research Site | Turku | Finland | ||
| 78 | Research Site | Berlin | Germany | ||
| 79 | Research Site | Gottingen | Germany | ||
| 80 | Research Site | Jena | Germany | ||
| 81 | Research Site | Leipzig | Germany | ||
| 82 | Research Site | München | Germany | ||
| 83 | Research Site | Naumburg | Germany | ||
| 84 | Research Site | Nurnberg | Germany | ||
| 85 | Research Site | Schwerin | Germany | ||
| 86 | Research Site | Siegen | Germany | ||
| 87 | Research Site | Balassagyarmat | Hungary | ||
| 88 | Research Site | Budapest | Hungary | ||
| 89 | Research Site | Gyor | Hungary | ||
| 90 | Research Site | Gyula | Hungary | ||
| 91 | Research Site | Kecskemét | Hungary | ||
| 92 | Research Site | Nyíregyháza | Hungary | ||
| 93 | Research Site | Bandung | West Java | Indonesia | |
| 94 | Research Site | Jakarta | Indonesia | ||
| 95 | Research Site | Seoul | Korea, Republic of | ||
| 96 | Research Site | Cebu City | Philippines | ||
| 97 | Research Site | Davao City | Philippines | ||
| 98 | Research Site | Mandaluyong City | Philippines | ||
| 99 | Research Site | Manila | Philippines | ||
| 100 | Research Site | Quezon City | Philippines | ||
| 101 | Research Site | Moscow | Russian Federation | ||
| 102 | Research Site | Saratov | Russian Federation | ||
| 103 | Research Site | St. Petersburg | Russian Federation | ||
| 104 | Research Site | Reading | Berkshire | United Kingdom | |
| 105 | Research Site | Crawley | West Sussex | United Kingdom | |
| 106 | Research Site | Blackpool | United Kingdom | ||
| 107 | Research Site | Bolton | United Kingdom | ||
| 108 | Research Site | Cardiff | United Kingdom | ||
| 109 | Research Site | Chorley | United Kingdom | ||
| 110 | Research Site | Coventry | United Kingdom | ||
| 111 | Research Site | Glasgow | United Kingdom | ||
| 112 | Research Site | Hamilton | United Kingdom | ||
| 113 | Research Site | Liverpool | United Kingdom | ||
| 114 | Research Site | Manchester | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Martin Brecher, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00314210
Other Study ID Numbers:
- D1448C00012
- EUDRACT Number: 2005-005055-18
First Posted:
Apr 13, 2006
Last Update Posted:
Mar 25, 2009
Last Verified:
Mar 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: