Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OPAL |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine fumarate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo | ||
| To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26474010 | Derived | McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416. | |
| 24816198 | Derived | Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Little Rock |
| Arkansas |
| United States |
| Research Site | Anaheim | California | United States |
| Research Site | El Centro | California | United States |
| Research Site | Garden Grove | California | United States |
| Research Site | National City | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Hartford | Connecticut | United States |
| Research Site | Wilmington | Delaware | United States |
| Research Site | Altamonte Springs | Florida | United States |
| Research Site | DeLand | Florida | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | New Port Richey | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Roswell | Georgia | United States |
| Research Site | Naperville | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Lafayette | Indiana | United States |
| Research Site | Owensboro | Kentucky | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Braintree | Massachusetts | United States |
| Research Site | Cambridge | Massachusetts | United States |
| Research Site | Pittsfield | Massachusetts | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research SIte | Staten Island | New York | United States |
| Research Site | Avon Lake | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Allentown | Pennsylvania | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | DeSoto | Texas | United States |
| Research Site | Houston | Texas | United States |
| 24175720 | Derived | Weisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520. |
| 24067192 | Derived | Clayton AH, Locklear JC, Svedsater H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25. |
| 23485955 | Derived | Thase ME, Montgomery S, Papakostas GI, Bauer M, Trivedi MH, Svedsater H, Locklear JC, Gustafsson U, Datto C, Eriksson H. Quetiapine XR monotherapy in major depressive disorder: a pooled analysis to assess the influence of baseline severity on efficacy. Int Clin Psychopharmacol. 2013 May;28(3):113-20. doi: 10.1097/YIC.0b013e32835fb971. |
| 20691481 | Derived | Bortnick B, El-Khalili N, Banov M, Adson D, Datto C, Raines S, Earley W, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in major depressive disorder: a placebo-controlled, randomized study. J Affect Disord. 2011 Jan;128(1-2):83-94. doi: 10.1016/j.jad.2010.06.031. Epub 2010 Aug 6. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| 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 |
Not provided
Not provided