RecruitingPHASE2INTERVENTIONAL

Pharmacologic Treatment Augmentation in Chronic Depression

This research study is for adults aged 18-64 who have had severe depression for a long time, even after trying at least two different antidepressant medications and at least 12 sessions of talking therapy. It's called 'treatment-resistant depression'. The study aims to see if adding ketamine infusions, a specific type of talking therapy called CBASP, or a combination of both, can help reduce depression symptoms. Participants will be carefully screened and then randomly assigned to one of three treatment groups. Researchers will monitor their progress closely with assessments, blood tests, and MRI scans. The goal is to find more effective treatments for chronic depression.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital Tuebingen

Enrolment target

Start

29 Apr 2024

Estimated completion

01 Jul 2026

Major Depressive Disorder

What is this study about?

This research is looking into new ways to help people who have chronic, or long-lasting, depression that hasn't responded well to standard treatments. This means you might have tried at least two different antidepressant medications and had many sessions of talking therapy, but your depression symptoms are still significantly affecting your life. The study wants to explore whether a medicine called ketamine, a specific type of talking therapy called Cognitive Behavioral Analysis System of Psychotherapy (CBASP), or a combination of both, could be more effective.

The researchers are particularly interested in understanding how these treatments might change brain activity. They will use special scans, called MRI scans, to look at your brain before, during, and after the study. This helps them learn more about how depression affects the brain and how different treatments might work to improve symptoms. The hope is that this research will lead to better treatment options for people struggling with severe, long-term depression.

By taking part, you could potentially help scientists find new and better ways to treat chronic depression in the future. The information gathered from people like you is really important for developing more effective and targeted therapies.

Key takeaways

This study explores new treatments for long-lasting, severe depression when other options haven't worked.
It tests ketamine, a specific therapy called CBASP, or a combination.
You must be 18-64 with depression resistant to at least two antidepressants and much therapy.
Participation involves screening, random assignment to a treatment group, regular therapy, blood tests, and MRI scans.
The aim is to find better treatments and understand how they affect the brain.

Who may be eligible?

This study is looking for adults aged between 18 and 64 years old. To be considered, you must have chronic depression, meaning it's been ongoing for a long time. This is specifically for people whose depression hasn't gotten much better even after trying at least two different antidepressant medications at proper doses and having at least 12 sessions of talking therapy like CBT or psychodynamic therapy.

You also need to be able to fully understand what participation involves and give your consent. There are certain reasons why you might not be able to join, such as having a primary problem with drug or alcohol misuse, certain brain conditions like a stroke, or other serious health issues that would make taking part unsafe. We'll also ask women who could become pregnant to use two reliable forms of contraception during the study, and men to use condoms if they have sex with women who could become pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 64 years old?
Have you had depression for a long time that hasn't significantly improved?
Have you tried at least two different antidepressant medications without much success?
Have you completed at least 12 sessions of talking therapy (like CBT) without major relief?
Are you able to understand and give permission to join a study?
Are you willing to use contraception if you could become pregnant or make someone pregnant?

Answer every question to see your result.

What does participation involve?

If you're interested, the first step is a thorough screening to see if the study is right for you. This involves a detailed chat about your medical and mental health history, a general physical check-up, a blood test (which includes a pregnancy test for women), and a heart trace (ECG). This screening takes about 1 hour and 40 minutes.

If you qualify, you'll be randomly put into one of three treatment groups: one will receive ketamine plus standard care, another will receive ketamine plus CBASP therapy, and the third will receive a placebo (dummy treatment) plus CBASP therapy. You'll have regular talking therapy sessions (two per week) over several weeks. Throughout the study, you'll have appointments to check your mood and symptoms, give blood samples, and have MRI scans of your brain. The study will carefully watch how you're responding to treatment and any side effects you might experience. After the main study period, you'll have follow-up care as part of standard practice, including another MRI scan. The exact total duration isn't specified, but it involves several weeks of active treatment and follow-up.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments for your depression that aren't widely available yet, which might help improve your symptoms if other treatments haven't worked. However, like all medical treatments, there are potential risks, such as side effects from ketamine or experiencing little to no benefit from the treatments. You might also find the assessments, such as blood tests and MRI scans, a bit inconvenient. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie
Verified postcode
Tübingen, Germany· Recruiting
Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie
Verified postcode
Jena, Germany· Recruiting

Common questions

What is 'treatment-resistant depression'?

This means your depression hasn't significantly improved after trying at least two different antidepressant medications and several sessions of talking therapy.

What is ketamine?

Ketamine is a medication that, in certain settings and doses, is being explored as a treatment for severe depression, often given by infusion.

What is CBASP?

CBASP stands for Cognitive Behavioral Analysis System of Psychotherapy. It's a specific type of talking therapy designed for chronic depression.

Will I know which treatment I'm getting?

You'll know if you're in a group receiving CBASP therapy. However, if you're in one of the CBASP groups, neither you nor your care team will know if you're receiving ketamine or a placebo (a dummy treatment that looks like ketamine).

What does a 'placebo' mean?

A placebo is an inactive substance or treatment that looks exactly like the real treatment. It helps researchers understand if the real medicine is truly effective, or if improvements might be due to other factors.

How to find out more

Martin Walter, Prof. Dr.

martin.walter@med.uni-jena.de +493641 9390101 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.