The Effect of a Four 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. (INTENSIFY MDD)

This parallel, randomised, controlled trial (n=418) will investigate the effect of a six-week ketamine for Major Depressive Disorder (MDD) compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.

Led by Dr. Inge Winter, UMC Utrecht, the study aims to address the significant distress and impairment caused by MDD, a common psychiatric illness affecting over 28 million people in the European Union. Currently, antidepressant medication is prescribed through a trial-and-error process, with esketamine nasal spray recently approved for patients with treatment-resistant MDD (TRD).

The trial will compare early-intensified pharmacological treatment to standard treatment, with primary outcomes measured through the Montgomery-Åsberg Depression Rating Scale (MADRS) at six weeks.

Secondary outcomes include changes in severity and improvement in global functioning, levels of depression and anxiety, cognitive performance, quality of life, and side effects.

Participants, aged 18 to 65, diagnosed with MDD without psychotic features, and experiencing their first treatment failure, will be enrolled. The study will be conducted across multiple centres in Austria, Germany, Italy, Spain, and the United Kingdom, with a projected start date of March 31, 2024, and an estimated completion date of June 30, 2026.

Topic Depression
Compound Ketamine
Country Austria Germany Italy Spain United Kingdom
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Trial Details



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Sponsors & Collaborators

Utrecht University
Some researchers at Utrecht University are working on a large psychedelics study with colleagues from Leiden University, but this university hasn't set up any department specifically for psychedelic studies.

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