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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001071-11 | EudraCT Number |
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The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo
According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AA24530: 5 mg | Experimental |
| |
| Lu AA24530: 10 mg | Experimental |
| |
| Lu AA24530: 20 mg | Experimental |
| |
| Duloxetine: 60 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AA24530 | Drug | per oral, once daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate, remission rate, and safety | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AU002 | Brisbane | 4000 | Australia | |||
| AU001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32242018 | Derived | Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5. | |
| 31087825 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 2007-001071-11 | EMA EudraCT Results | View IPD |
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| Duloxetine | Drug | per oral, once daily for 6 weeks |
|
| Placebo | Drug | per oral, once daily for 6 weeks |
|
| Brisbane |
| 4053 |
| Australia |
| AU003 | Dandenc | 3175 | Australia |
| AU004 | Epping | 3076 | Australia |
| AU006 | Malvern | 3144 | Australia |
| AT001 | Vienna | 1090 | Austria |
| AT002 | Vienna | Austria |
| AT003 | Vienna | Austria |
| BE003 | Diest | 2930 | Belgium |
| BE002 | Sint-Niklaas | 9100 | Belgium |
| CA006 | Mississauga | L5M 4N4 | Canada |
| CA004 | Oakville | L6J 7W5 | Canada |
| CA003 | Penticton | V2A 4M4 | Canada |
| CA005 | Toronto | M4S 1Y2 | Canada |
| CA001 | Vancouver | V6Z 2L4 | Canada |
| CZ002 | Brno | 60200 | Czechia |
| CZ005 | Prague | 12000 | Czechia |
| CZ001 | Prague | 15030 | Czechia |
| CZ004 | Prague | 158 00 | Czechia |
| CZ003 | Prague | 16000 | Czechia |
| CZ006 | Sternberk | 78517 | Czechia |
| FI001 | Helsinki | 00260 | Finland |
| FI003 | Helsinki | 00530 | Finland |
| FI006 | Jarvenpaa | Finland |
| FI004 | Seinäjoki | Finland |
| FI005 | Tampere | Finland |
| FI002 | Turku | 20100 | Finland |
| FR007 | Angoulême | 16000 | France |
| FR002 | Dole | 39100 | France |
| FR003 | Montpellier | 34000 | France |
| FR001 | Orvault | 44700 | France |
| FR008 | Rouen | 76000 | France |
| FR004 | Savigny-sur-Orge | 91600 | France |
| FR005 | Wattigny | 59139 | France |
| IN001 | Ahmedabab | India |
| IN009 | Ahmedabad | India |
| IN007 | Chennai | 3 | India |
| IN006 | Hyderabaad | 500 034 | India |
| IN003 | Mangalore | 574160 | India |
| IN002 | Pune | 411004 | India |
| LT002 | Kaunas | 50185 | Lithuania |
| LT003 | Klaipėda | 91251 | Lithuania |
| LT001 | Vilnius | Lithuania |
| MY002 | Kuala Lumpur | 55100 | Malaysia |
| MY003 | Kuala Lumpur | 59100 | Malaysia |
| NO004 | Fredrikstad | 1606 | Norway |
| NO001 | Hamar | 2315 | Norway |
| NO003 | Skien | 3725 | Norway |
| PH002 | Las Piñas | 1701 | Philippines |
| PH003 | Mandaluyong | Philippines |
| PH001 | Mandaue City | 6014 | Philippines |
| RU005 | Arkhangelsk | 163061 | Russia |
| RU002 | Nikol'skoye | 188357 | Russia |
| RU003 | Saint Petersburg | 190005 | Russia |
| RU004 | Saratov | 410028 | Russia |
| RU001 | Tomsk | 634014 | Russia |
| RS004 | Belgrade | 11000 | Serbia |
| RS002 | Kragujevac | 34000 | Serbia |
| KR003 | Gwangju | 501-757 | South Korea |
| KR002 | Seoul | 120-752 | South Korea |
| KR001 | Seoul | 138-746 | South Korea |
| SE006 | Halmstad | 301 85 | Sweden |
| SE001 | Linköping | 581 85 | Sweden |
| SE002 | Lund | 223 61 | Sweden |
| SE003 | Malmö | 21237 | Sweden |
| SE005 | Stockholm | 112 34 | Sweden |
| SE004 | Uppsala | 753 19 | Sweden |
| UA003 | Dnipro | 49005 | Ukraine |
| UA005 | Kharkiv | 61068 | Ukraine |
| UA002 | Kyiv | 4080 | Ukraine |
| UA004 | Lviv | 79021 | Ukraine |
| UA001 | Odesa | 65006 | Ukraine |
| Derived |
| Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000722514 | Tedatioxetine |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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