Study on Ketamine and CBASP for Treating Chronic Depression in Adults

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for chronic depression, a long-lasting form of depression that can significantly impact daily life. The study will explore the use of ketamine hydrochloride, a medication that is administered as a solution for injection, to see if it can help reduce symptoms of depression. Participants will be divided into different groups to compare the effects of ketamine combined with a specific type of therapy called CBASP (Cognitive Behavioral Analysis System of Psychotherapy) against a placebo combined with CBASP, and ketamine combined with treatment as usual (TAU).

The purpose of the study is to determine if the combination of ketamine and CBASP can lead to a greater reduction in depressive symptoms compared to the other treatment combinations. The study will last for several weeks, during which participants will receive their assigned treatments and have their symptoms monitored. The main goal is to see if there is a noticeable improvement in depression symptoms from the start of the treatment to six weeks after the treatment ends.

Throughout the study, participants’ depressive symptoms will be assessed using a standardized tool called the Montgomery–Åsberg Depression Rating Scale (MADRS). This scale is widely used by clinicians to evaluate the severity of depression. The assessments will be conducted by a person who is not involved in the treatment to ensure unbiased results. The study aims to provide valuable insights into the potential benefits of ketamine as part of a treatment plan for chronic depression.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of chronic depression. This includes evaluating the history of depressive episodes and treatment resistance.

Eligibility is determined based on age (18-64 years) and the ability to adhere to the study schedule.

2 randomization

Participants are randomly assigned to one of three groups: ketamine plus CBASP (Cognitive Behavioral Analysis System of Psychotherapy), placebo plus CBASP, or ketamine plus TAU (Treatment As Usual).

3 treatment phase

The treatment phase involves receiving either ketamine hydrochloride or a placebo through intravenous infusion. The specific dosage and frequency are determined by the study protocol.

Participants in the ketamine groups receive Ketamin Inresa, a solution for injection, while those in the placebo group receive an isotonic saline solution.

4 monitoring and evaluation

Throughout the study, depressive symptoms are assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS). This is conducted by an independent rater who is unaware of the treatment group assignments.

The primary objective is to measure the reduction in depressive symptoms from the start of the treatment to six weeks after its completion.

5 follow-up

After the treatment phase, follow-up assessments are conducted to evaluate the long-term effects of the treatment on depressive symptoms.

The study is expected to conclude by May 3, 2027.

Who Can Join the Study?

Must be between 18 and 64 years old.
Must have a diagnosis of chronic depression. This means having repeated episodes of depression that are severe or moderate, with no full recovery between episodes for at least two months, or having a current episode lasting two or more years.
Must have treatment-resistant depression. This means the depression continues even after trying at least two different antidepressant medications from two different categories.
Must have tried at least 12 sessions of psychotherapy, which includes types like psychoanalysis, depth psychology-based therapy, or cognitive behavior therapy, but still have symptoms of chronic depression.
Must be able to understand and voluntarily sign the informed consent form, which is a document explaining the study and agreeing to participate.
Must be able to follow the study visit schedule and meet other study requirements.
Must agree to use contraception, which means using methods to prevent pregnancy, if applicable.

Who Cannot Join the Study?

Having a diagnosis of chronic depression. This means a long-term form of depression that lasts for a long time.
Being outside the age range specified for the study. The study may have specific age limits for participants.
Being part of a vulnerable population. This could include groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Kwdeondl dhb Ubfefjjsdxsh Moxpntpo Aci	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	27.03.2024

Trial locations

Investigated drugs:

Ketamine is being studied for its potential to reduce symptoms of chronic depression. In this trial, it is used in combination with other therapies to see if it can enhance the treatment effects for patients who have not responded well to traditional treatments.

CBASP (Cognitive Behavioral Analysis System of Psychotherapy) is a type of psychotherapy specifically designed for chronic depression. It focuses on helping patients understand the impact of their behavior on others and learn new ways to interact and solve problems. In this trial, it is used alongside ketamine to evaluate the combined effect on depressive symptoms.

TAU (Treatment As Usual) refers to the standard care that patients typically receive for chronic depression. This can include medications, therapy, or a combination of both. In this study, TAU is used as a comparison to see how the addition of ketamine might improve outcomes for patients.

Chronic Depression – Chronic depression, also known as persistent depressive disorder, is a long-term form of depression. It is characterized by a continuous feeling of sadness and lack of interest in daily activities. Individuals with this condition may experience low self-esteem, feelings of hopelessness, and difficulty concentrating. The symptoms are less severe than major depressive disorder but last for a longer period, often for years. People with chronic depression may also experience changes in appetite and sleep patterns. The condition can affect daily functioning and quality of life, requiring ongoing management.

Trial ID:

2024-512478-86-00

Protocol code:

Ketamin plus CBASP

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ketamine and CBASP for Treating Chronic Depression in Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?