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| ID | Type | Description | Link |
|---|---|---|---|
| 67953964MDD3004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the socio-demographic, disease-related and treatment-related characteristics, and the standard of care (SOC) treatment patterns of participants with major depressive disorder (MDD) with anhedonia with inadequate response to their current antidepressant treatments and treated according to the standard of care treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDD Participants With Anhedonia | Data will be collected, for major depressive disorder (MDD) participants with anhedonia who have had an inadequate response to a standard of care (SOC) antidepressant treatment, from participant's source medical records from routine clinical practice over a period of 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | There is no interventional treatment administered to the participants as a part of this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Different Socio-demographic Characteristics | Distribution of participants with different demographic characteristics will be assessed. | Day 1 |
| Percentage of Participants with Disease-related Characteristics | Percentage of participants with disease-related characteristics which includes diagnosis/ disease history and psychiatric/ general medical comorbidities, will be reported. | Day 1 |
| Percentage of Participants With Type of Therapies and Treatment Strategies | Percentage of participants with type of therapies (such as augmentation, combination therapy, etc.) and treatment strategies will be reported. | Day 1 |
| Time to Next Antidepressant Treatment | Time to next antidepressant treatment will be reported. | Up to 12 months |
| Percentage of Participants with Recurrence or Relapse | Percentage of participants with recurrence or relapse will be reported. | Up to 12 months |
| Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score | Change from baseline in CSFQ-14 total score will be reported. The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items). Each question rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consists of participants with MDD with anhedonia who have had an inadequate response to an antidepressant.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham 1 |
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| Baseline, up to 12 months |
| Percentage of Participants With Patient Global Impression of Severity (PGI-S) Scale Score for Sexual Functioning | Percentage of participants with PGI-S scale score for sexual functioning will be reported. The PGI-S is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater disease severity. | Up to 12 months |
| Homewood |
| Alabama |
| 35209 |
| United States |
| ATP Clinical Research | California City | California | 92626 | United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| Flagler Hospital and Florida Center for TMS | Saint Augustine | Florida | 32086 | United States |
| Center for Revitalizing Psychiatry | Sarasota | Florida | 34237 | United States |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | 33629 | United States |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | 30338 | United States |
| Psych Atlanta, P.C. | Marietta | Georgia | 30060 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Baber Research Group | Naperville | Illinois | 60563 | United States |
| Lumin Health | Newton | Massachusetts | 02459 | United States |
| Univeristy of Massachusetts | Worcester | Massachusetts | 01605-2610 | United States |
| Missouri University Health Care South Providence Psychiatry | Columbia | Missouri | 65201 | United States |
| Signature Research Associates Inc. | Fairlawn | Ohio | 44333 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Seattle Neuropsychiatric Treatment Center | Tacoma | Washington | 98405-1954 | United States |
| Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales | Buenos Aires | C1133AAH | Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Hospital Fleni | Ciudad Autonoma Buenos Aires | C1428AQK | Argentina |
| CEN Consultorios Especializados en Neurociencias | Córdoba | 5000FJF | Argentina |
| Instituto Medico DAMIC | Córdoba | X5003DCE | Argentina |
| Centro Medico Luquez | Córdoba | X5006IKK | Argentina |
| Resolution | Mendoza | M5502AHV | Argentina |
| Hospital Sao Vicente de Paulo | Passo Fundo | 99010-080 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | Sao Jose Rio Preto | 15090 000 | Brazil |
| Centro Integrado Facili | São Bernardo do Campo | 09726 150 | Brazil |
| Clinica Viver - Centro de Desospitalizacao Humana | São Paulo | 04020-060 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | 05403-000 | Brazil |
| The Medical Arts Health Research Group | West Vancouver | British Columbia | V7T 1C5 | Canada |
| Providence Care Hospital | Kingston | Ontario | K7L 4X3 | Canada |
| Introspect Clinic | Ontario | Ontario | K1C 1E9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Jodha Tishon Inc. | Toronto | Ontario | M5S 3A3 | Canada |
| CHU Angers - Hopital Hotel Dieu | Angers | 49100 | France |
| CHU Clermont-Ferrand - Hopital Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| Cabinet Medical des Drs Prizac-Desbonnet Scottez | Douai | 59500 | France |
| CHU de Grenoble - Hôpital Sud | Isere | 38043 | France |
| Hopital la Colombiere | Montpellier | 34295 | France |
| CHU de Nantes hotel Dieu | Nantes | 44093 | France |
| Cabinet De Psychiatrie Neurostim | Paris | 75005 | France |
| Groupe Hospitalier Pitie-Salpetriere | Paris | 75013 | France |
| Hopital Sainte Musse | Toulon | 83100 | France |
| Universitaetsklinikum der RWTH Aachen | Aachen | 52074 | Germany |
| Praxis Dr. med. Kirsten Hahn | Berlin | 13187 | Germany |
| Vivantes Klinikum Spandau | Berlin | 13585 | Germany |
| Universitaetsklinikum Frankfurt | Frankfurt | 60528 | Germany |
| Universitatsklinikum Jena | Jena | 07743 | Germany |
| Universitatsmedizin der Johannes Gutenberg Universitat Mainz | Mainz | 55131 | Germany |
| Pharmakologisches Studienzentrum Chemnitz GmbH | Mittweida | 09648 | Germany |
| Gemeinschaftspraxis Prof. Steinbach und Dr. Steib | Nuremberg | 90402 | Germany |
| Praxis Kuehn | Oranienburg | 16515 | Germany |
| Praxis Dipl.-med. Stefan Kusserow | Stralsund | 18439 | Germany |
| ASL ROMA | Colleferro | 00034 | Italy |
| Ospedale Policlinico San Martino IRCCS | Genova | 16132 | Italy |
| AUSL LE di Lecce | Lecce | 73100 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora | Milan | 20122 | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | 43125 | Italy |
| Universita degli Studi di Perugia | Perugia | 06123 | Italy |
| Policlinico Tor Vergata | Roma | 00133 | Italy |
| University of Siena | Siena | 53100 | Italy |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| CHA University ilsan Medical Center | Goyang | 10414 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Jeju National University Hospital | Jeju Special | 63241 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Hallym University Kangdong Sacred Heart Hospital | Seoul | 05355 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Gral. de Villalba | Collado Villalba | 28400 | Spain |
| Hosp. de Jerez de La Frontera | Jerez de la Frontera | 11407 | Spain |
| Hosp. Univ. Infanta Leonor | Madrid | 28031 | Spain |
| Csm Fuencarral | Madrid | 28035 | Spain |
| Hosp Regional Univ de Malaga | Málaga | 29009 | Spain |
| Hosp. El Bierzo | Ponferrada | 24404 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46126 | Spain |
| Hosp. Prov. de Zamora | Zamora | 49021 | Spain |
| Gustavsbergs Vardcentral | Gustavsberg | 13440 | Sweden |
| Affecta Pskyiatrimottagning | Halmstad | SE-30248 | Sweden |
| ProbarE i Lund AB | Lund | 22222 | Sweden |
| ONE LIFETIME Lakarmottagning | Skövde | SE-54150 | Sweden |
| Abraham Cowley Unit | Chertsey | KT16 9AU | United Kingdom |
| Kingsway Hospital | Derby | DE22 3LZ | United Kingdom |
| Wonford House Hospital | Exeter | EX2 5AF | United Kingdom |
| Kings College Hospital | London | SE5 8AF | United Kingdom |
| Greater Manchester Mental Health NHSFT | Manchester | M25 3BL | United Kingdom |
| Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| Lincolnshire Partnership NHS Foundation Trust (LPFT) | Sleaford | NG34 8GG | United Kingdom |
| Moorgreen Hospital | Southampton | SO30 3JB | United Kingdom |
| St Georges Hospital | Stafford | ST16 3AG | United Kingdom |
| South West Yorkshire Trust | Wakefield | WF1 3SP | United Kingdom |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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