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Study on Ketamine and CBASP for Treating Chronic Depression in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

Ketamine – Ketamine is administered intravenously and is currently being studied in clinical trials for its potential to treat chronic depression. It is known for its rapid antidepressant effects, which are being evaluated in combination with other therapies. Ketamine works by blocking NMDA receptors in the brain, which are involved in mood regulation. It is classified as a dissociative anesthetic and is being explored for its ability to quickly reduce depressive symptoms.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512478-86-00Protocol codeKetamin plus CBASPEstimated enrolment60 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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