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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005054-46 | |||
| Silver |
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The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine fumarate | Drug | |||
| Paroxetine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate efficacy by evaluating response rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seroquel Medical Science Director | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | City Bell | Buenos Aires | Argentina | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24394383 | Derived | Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026. | |
| 22143997 | Derived | Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6. |
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| Godoy Cruz |
| Mendoza Province |
| Argentina |
| Research Site | Mendoza | Mendoza Province | Argentina |
| Research Site | Rosario | Santa Fe Province | Argentina |
| Research Site | Buenos Aires | Argentina |
| Research Site | Córdoba | Argentina |
| Research Site | La Plata | Argentina |
| Research Site | Kardzhali | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Veliko Tarnovo | Bulgaria |
| Research Site | Vratsa | Bulgaria |
| Research Site | Kelowna | British Columbia | Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Miramichi | New Brunswick | Canada |
| Research Site | Corner Brook | Newfoundland and Labrador | Canada |
| Research Site | Sydney | Nova Scotia | Canada |
| Research Site | Brantford | Ontario | Canada |
| Research Site | Chatham | Ontario | Canada |
| Research Site | Markham | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Orléans | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Gatineau | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Saskatoon | Saskatchewan | Canada |
| Research Site | Brno | Czechia |
| Research Site | Litoměřice | Czechia |
| Research Site | Olomouc | Czechia |
| Research Site | Pilsen | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Prerova | Czechia |
| Research Site | Prostojov | Czechia |
| Research Site | Aarhus | Denmark |
| Research Site | Copenhagen | Denmark |
| Research Site | Frederiksberg | Denmark |
| Research Site | Helsinki | Finland |
| Research Site | Jarvenpaa | Finland |
| Research Site | Salo | Finland |
| Research Site | Turku | Finland |
| Research Site | Angoulême | France |
| Research Site | Arcachon | France |
| Research Site | Cherbourg | France |
| Research Site | Élancourt | France |
| Research Site | La Valette-du-Var | France |
| Research Site | Le Pecq | France |
| Research Site | Nîmes | France |
| Research Site | Rennes | France |
| Research Site | Toulouse | France |
| Research Site | Bad Saarow | Germany |
| Research Site | Berlin | Germany |
| Research Site | Bochum | Germany |
| Research Site | Göttingen | Germany |
| Research Site | Hamburg | Germany |
| Research Site | München | Germany |
| Research Site | Siegen | Germany |
| Research Site | Distrito Federal | Mexico |
| Research Site | Guadalajara | Mexico |
| Research Site | México | Mexico |
| Research Site | Brattvåg | Norway |
| Research Site | Oslo | Norway |
| Research Site | Paradis | Norway |
| Research Site | Bucharest | Romania |
| Research Site | Piteşti | Romania |
| Research Site | Sibiu | Romania |
| Research Site | Bojnice | Slovakia |
| Research Site | Bratislava | Slovakia |
| Research Site | Brezno | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Liptovský Mikuláš | Slovakia |
| Research Site | Zilina-Bytcica | Slovakia |
| Research Site | Bloemfontein | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Barcelona | Spain |
| Research Site | Madrid | Spain |
| Research Site | Oviedo | Spain |
| Research Site | Salamanca | Spain |
| Research Site | Linköping | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Malmö | Sweden |
| Research Site | Sundsvall | Sweden |
| Research Site | Uppsala | Sweden |
| 19691907 | Derived | Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20. |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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