Condition: Major Depressive Disorder · Treatment Resistant Depression · Sponsor: Dr. Inge Winter
Over 28 million people suffer from current depressive disorder in the European Union. Major depressive disorder (MDD) is one of the most common psychiatric illnesses. The symptoms cause clinically significant distress or impairment in social, occupational, and other important areas of functioning. To treat MDD, there are several antidepressants available and prescribing medication is a process of trial-and-error. Guidelines do not explicitly advise on the order in which antidepressant medication should be prescribed. The choice of antidepressant should be tailored to the patient, while involving the patient in the decision-making process. In general, the choice for the first- and second-line treatment will be a second-generation antidepressant. Recently, esketamine nasal spray (intranasal (IN) administration) was approved for patients with treatment-resistant MDD (TRD). A patient is diagnosed with TRD when having used two antidepressants in sufficient duration and adequate dose without sufficient effect. TRD is associated with a negative impact on quality of life, higher risk for hospitalisations and suicide, comorbidities, poorer social and occupational functioning and a high carer burden. The efficacy of intranasal use of esketamine has been demonstrated in MDD subjects with treatment-resistant symptoms but also in subjects with non-treatment resistant depression, and is approved by the FDA and EMA as a third-line treatment. Besides the registered esketamine nasal spray, wh…
This description comes directly from the study's public registry record.
Inge Winter, Dr. · +31875553227 · i.winter@umcutrecht.nl
Cynthia Okhuijsen-Pfeifer, Dr. · +31875553227 · c.pfeifer@umcutrecht.nl
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| Medical University Innsbruck | Innsbruck, Austria | Recruiting |
| Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld | Bielefeld, Germany | Recruiting |
| LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft | Dortmund, Germany | Recruiting |
| University Hospital Frankfurt am Main - Goethe University | Frankfurt am Main, Germany | Recruiting |
| Westfälische Wilhelms-Universität Münster | Münster, Germany | Recruiting |
| Eginition Hospital, department of psychiatry | Athens, Greece | Not Yet Recruiting |
| Universita degli Studi di Brescia | Brescia, Italy | Not Yet Recruiting |
| University of Cagliari | Cagliari, Italy | Recruiting |
| Università degli studi della Campania Luigi Vanvitelli | Naples, Italy | Recruiting |
| Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino" | Turin, Italy | Not Yet Recruiting |
| Fundació Clínic per a la Recerca Biomèdica | Barcelona, Spain | Recruiting |
| King's College London, Psychiatry & Cognitive Neuroscience | London, United Kingdom | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05973851