Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment approach for individuals with major depressive disorder who have not responded to their initial treatment. The study will compare a six-week intensified medication regimen to the usual treatment methods. The medications being tested include atomoxetine, reboxetine, fluvoxamine, agomelatine, ketamine, tianeptine, citalopram hydrobromide, duloxetine, amitriptyline hydrochloride, esketamine, paroxetine hydrochloride, bupropion hydrochloride, clomipramine hydrochloride, mianserin hydrochloride, escitalopram, dosulepin hydrochloride, sertraline hydrochloride, fluoxetine hydrochloride, nortriptyline hydrochloride, venlafaxine, milnacipran hydrochloride, mirtazapine, desvenlafaxine benzoate, imipramine hydrochloride, vortioxetine, and trazodone. Some participants will receive a placebo for comparison.

The purpose of the study is to determine if the intensified treatment can improve symptoms more effectively than the standard treatment. Participants will be randomly assigned to either the intensified treatment group or the usual treatment group. The study will last for six weeks, during which participants will have regular check-ups to monitor their progress and any changes in their symptoms. The study aims to measure the severity of depression symptoms and any improvements over time using a scale called the Montgomery Åsberg Depression Rating Scale (MADRS).

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The study will also assess the impact of the treatment on participants’ quality of life and daily functioning. The results will help determine if the intensified treatment approach is more effective for those who have not responded to their first-line treatment for major depressive disorder.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will provide written consent to participate. If needed, a legal guardian can co-sign the consent form.

A pregnancy test will be conducted for female participants of childbearing potential. This is to ensure safety during the trial.

Your primary diagnosis of major depressive disorder will be confirmed using a structured interview.

Your current treatment failure will be assessed, and your intention to change treatment will be confirmed.

2 baseline assessment

A baseline assessment will be conducted to evaluate the severity of your symptoms using the Montgomery Åsberg Depression Rating Scale (MADRS).

Your functional impairment will be assessed using the Sheehan Disability Scale (SDS).

3 treatment phase

You will be randomly assigned to one of two treatment groups: early-intensified pharmacological treatment (EIPT) or treatment as usual (TAU).

The treatment phase will last for six weeks. During this time, you will take medications as prescribed. The specific medication, dosage, and frequency will be determined by the study protocol and your assigned group.

4 mid-treatment visit

A mid-treatment visit will occur to monitor your progress and any side effects. Your symptoms will be reassessed using the MADRS.

You will also complete assessments related to anxiety, depression, quality of life, and cognitive function.

5 end of treatment visit

At the end of the six-week treatment period, a final assessment will be conducted.

Your symptoms will be evaluated again using the MADRS, and other assessments will be repeated to measure changes in your condition.

The presence of any side effects will be recorded, and your overall treatment experience will be reviewed.

Who Can Join the Study?

Participants must be either inpatients or outpatients and be between the ages of 18 and 65.
Participants must be willing and able to provide written informed consent. If needed, a legal guardian can also sign the consent form.
Female participants who can have children must use effective birth control during the trial and have a negative pregnancy test at the start of the study.
Participants must have a primary diagnosis of major depressive disorder without psychotic features, confirmed by a structured interview.
Participants must be experiencing their first treatment failure with their current medication for major depressive disorder, which was taken for at least 4 weeks at the recommended dose.
Participants must have failed their current medication for the current episode, as confirmed by a specific clinical assessment.
Participants and their clinician must plan to change their current medication.
Participants must have a certain level of symptom severity and experience difficulties in daily functioning. This means having a score of 20 or higher on a specific depression rating scale and a score of 5 or higher on any part of a disability scale.

Who Cannot Join the Study?

Patients who have not experienced a first-time treatment failure on their first-line treatment for major depressive disorder cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not willing or able to comply with the study procedures cannot participate.
Patients with any other medical condition that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients with a history of substance abuse or dependency that might interfere with the study cannot participate.
Patients who have a known allergy or sensitivity to the study medication cannot participate.
Patients who have a serious or unstable medical condition that might interfere with the study cannot participate.
Patients who have a history of non-compliance with medical treatment cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
University Of Brescia	Brescia	Italy
Eginitio Hospital	Athens	Greece
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
University Of Frankfurt	Frankfurt	Germany
Lkeffbifas Dsaprvtq	Dortmund	Germany
Utlikbjzydrmyojtkq fja Pbovoaqaezw ucj Pmlaauvfwkmppe Baffhsnfp	Bielefeld	Germany
Crunlko Pspyasotpjsrc 1yh fximi	Cagliari	Italy
Acszgcy Oqrmcrorcgm Ulhluddnykuev Cyqcrxhzameq Drsgj Scnvdf E Ducjk Srwltgp Dn Tnjjya	Turin	Italy

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.01.2024
Germany	Recruiting	01.01.2024
Greece	Not yet recruiting	01.01.2024
Italy	Recruiting	01.01.2024
Spain	Recruiting	01.01.2024

Trial locations

Investigated drugs:

Intensified Pharmacological Treatment is a special approach used in this trial to help people with major depressive disorder who did not get better with their first treatment. This treatment involves using a combination of medications that are adjusted and intensified over a six-week period. The goal is to see if this approach can reduce the symptoms of depression more effectively than the usual treatment methods. The specific medications used in this intensified treatment are not listed, but they are chosen to work together to improve mood and reduce depression symptoms.

Treatment as Usual refers to the standard care that patients typically receive for major depressive disorder. This usually involves medications that are commonly prescribed to help manage depression symptoms. In this trial, the usual treatment is used as a comparison to see if the intensified pharmacological treatment provides better results. The specific medications in the usual treatment are not detailed, but they are the ones typically used by doctors to help patients with depression.

Major depressive disorder – Major depressive disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It often involves changes in sleep, appetite, and energy levels, as well as difficulties in concentration and decision-making. The disorder can lead to emotional and physical problems, affecting a person’s ability to function in daily life. Symptoms can vary in intensity and may occur in episodes that last for weeks or months. The progression of the disorder can involve recurrent episodes, with periods of remission in between. Over time, the severity and frequency of episodes can change, impacting overall well-being and quality of life.

Trial ID:

2023-506617-21-00

Protocol code:

INTENSIFY MDD

NCT ID:

NCT05973851

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?