Anxiety Disorders Clinical Trial
— PLATINUMOfficial 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
| Verified date | March 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 575 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Brisbane | Queensland |
| Australia | Research Site | Everton Park | Queensland |
| Australia | Research Site | Malvern | Victoria |
| Australia | Research Site | Prahran | Victoria |
| Australia | Research Site | West Burleigh | Queensland |
| Canada | Research Site | Bathurst | New Brunswick |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Gatineau | Quebec |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Kingston | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Orleans | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Waterloo | Ontario |
| Finland | Research Site | Helsinki | |
| Finland | Research Site | Joensuu | |
| Finland | Research Site | Kuopio | |
| Finland | Research Site | Oulu | |
| Finland | Research Site | Pori | |
| Finland | Research Site | Seinajoki | |
| Finland | Research Site | Turku | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Gottingen | |
| Germany | Research Site | Jena | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | München | |
| Germany | Research Site | Naumburg | |
| Germany | Research Site | Nurnberg | |
| Germany | Research Site | Schwerin | |
| Germany | Research Site | Siegen | |
| Hungary | Research Site | Balassagyarmat | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Gyor | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Kecskemét | |
| Hungary | Research Site | Nyíregyháza | |
| Indonesia | Research Site | Bandung | West Java |
| Indonesia | Research Site | Jakarta | |
| Korea, Republic of | Research Site | Seoul | |
| Philippines | Research Site | Cebu City | |
| Philippines | Research Site | Davao City | |
| Philippines | Research Site | Mandaluyong City | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Quezon City | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | St. Petersburg | |
| United Kingdom | Research Site | Blackpool | |
| United Kingdom | Research Site | Bolton | |
| United Kingdom | Research Site | Cardiff | |
| United Kingdom | Research Site | Chorley | |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Crawley | West Sussex |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Hamilton | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Reading | Berkshire |
| United States | Research Site | Allentown | Pennsylvania |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Avon Lake | Ohio |
| United States | Research Site | Beechwood | Ohio |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Cambridge | Massachusetts |
| United States | Research Site | Cedarhurst | New York |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Coeur D'alene | Idaho |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Coral Springs | Florida |
| United States | Research Site | Deland | Florida |
| United States | Research Site | Desoto | Texas |
| United States | Research Site | Fresno | California |
| United States | Research Site | Ft Myers | Florida |
| United States | Research Site | Gainsville | Florida |
| United States | Research Site | Glen Burnie | Maryland |
| United States | Research Site | Havertown | Pennsylvania |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Hoffman Estates | Illinois |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | La Mesa | California |
| United States | Research Site | Lafayette | Indiana |
| United States | Research Site | Libertyville | Illinois |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Mesa | Arizona |
| United States | Research SIte | Middleburg Heights | Ohio |
| United States | Research Site | Midvale | Utah |
| United States | Research Site | N. Charleston | South Carolina |
| United States | Research Site | New York | New York |
| United States | Research Site | North Miami | Florida |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Owensboro | Kentucky |
| United States | Research Site | Paducah | Kentucky |
| United States | Research Site | Peoria | Arizona |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Piscataway | New Jersey |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pittsfield | Massachusetts |
| United States | Research Site | Prairie Village | Kansas |
| United States | Research Site | Redlands | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Roswell | Georgia |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | St Charles | Missouri |
| United States | Research Site | St Petersberg | Florida |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Valparaiso | Indiana |
| United States | Research Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Australia, Canada, Finland, Germany, Hungary, Indonesia, Korea, Republic of, Philippines, Russian Federation, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time from randomisation to occurrence of an anxiety event | |||
| Secondary | Occurrence of an anxiety event | |||
| Secondary | Change from randomisation in HAM-A/CGI-S scores | |||
| Secondary | In HAM-A psychic/somatic anxiety factor scores | |||
| Secondary | In MADRS total score and in MADRS item 10 score (suicidal thought) | |||
| Secondary | Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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