Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Diamond |
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
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine fumarate | Drug | |||
| Duloxetine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from randomization to Week 6 in the Montgomery-Ã…sberg Depression Rating Scale (MADRS) total score |
| Measure | Description | Time Frame |
|---|---|---|
| Change from randomization to each assessment in the MADRS total score | ||
| MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Art Lazarus, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 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
Not provided
| Scottsdale |
| Arizona |
| United States |
| Research Site | Beverly Hills | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Sherman Oaks | California | United States |
| Research Site | Wildomar | California | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Bradenton | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Edwardsville | Illinois | United States |
| Research Site | Lake Charles | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Haverhill | Massachusetts | United States |
| Research Site | Okemos | Michigan | United States |
| Research Site | Saint Paul | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Princeton | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | New York | New York | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Mayfield Village | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Salem | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Morgantown | West Virginia | 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. |
| 23673347 | Derived | Trivedi MH, Bandelow B, Demyttenaere K, Papakostas GI, Szamosi J, Earley W, Eriksson H. Evaluation of the effects of extended release quetiapine fumarate monotherapy on sleep disturbance in patients with major depressive disorder: a pooled analysis of four randomized acute studies. Int J Neuropsychopharmacol. 2013 Sep;16(8):1733-44. doi: 10.1017/S146114571300028X. Epub 2013 May 14. |
| 23497790 | Derived | Vieta E, Bauer M, Montgomery S, McIntyre RS, Szamosi J, Earley WR, Eriksson H. Pooled analysis of sustained response rates for extended release quetiapine fumarate as monotherapy or adjunct to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2013 Sep 5;150(2):639-43. doi: 10.1016/j.jad.2013.01.052. Epub 2013 Mar 14. |
| 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. |
| 22027845 | Derived | Weisler RH, Montgomery SA, Earley WR, Szamosi J, Lazarus A. Efficacy of extended release quetiapine fumarate monotherapy in patients with major depressive disorder: a pooled analysis of two 6-week, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2012 Jan;27(1):27-39. doi: 10.1097/YIC.0b013e32834d6f91. |
| 19358790 | Derived | Cutler AJ, Montgomery SA, Feifel D, Lazarus A, Astrom M, Brecher M. Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study. J Clin Psychiatry. 2009 Apr;70(4):526-39. doi: 10.4088/jcp.08m04592. Epub 2009 Apr 7. |
| 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 |
| D000068736 | Duloxetine Hydrochloride |
| 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 |
| D013876 | Thiophenes |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided