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Study identifier: NCT05973851 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Condition: Major Depressive Disorder · Treatment Resistant Depression  ·  Sponsor: Dr. Inge Winter

PhasePhase 3
Planned participants418
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

Talk to the study team

Inge Winter, Dr.  ·  +31875553227  ·  i.winter@umcutrecht.nl

Cynthia Okhuijsen-Pfeifer, Dr.  ·  +31875553227  ·  c.pfeifer@umcutrecht.nl

Always discuss trial participation with your own doctor first.

Locations (12)

Medical University InnsbruckInnsbruck, AustriaRecruiting
Universitätsklinik für Psychiatrie und Psychotherapie BielefeldBielefeld, GermanyRecruiting
LWL-Klinik Dortmund, Bereich Forschung & WissenschaftDortmund, GermanyRecruiting
University Hospital Frankfurt am Main - Goethe UniversityFrankfurt am Main, GermanyRecruiting
Westfälische Wilhelms-Universität MünsterMünster, GermanyRecruiting
Eginition Hospital, department of psychiatryAthens, GreeceNot Yet Recruiting
Universita degli Studi di BresciaBrescia, ItalyNot Yet Recruiting
University of CagliariCagliari, ItalyRecruiting
Università degli studi della Campania Luigi VanvitelliNaples, ItalyRecruiting
Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"Turin, ItalyNot Yet Recruiting
Fundació Clínic per a la Recerca BiomèdicaBarcelona, SpainRecruiting
King's College London, Psychiatry & Cognitive NeuroscienceLondon, United KingdomNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT05973851