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Study on the Effects of D-Cycloserine and Brain Stimulation for Patients with Major Depressive Disorder

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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 Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The study will explore the use of a medication called D-cycloserine (DCS) in combination with a technique known as transcranial magnetic stimulation (TMS). TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain, which may help improve symptoms of depression.

The purpose of the study is to investigate whether adding D-cycloserine to a single day of accelerated TMS can enhance its antidepressant effects. Participants will receive either the medication or a placebo alongside TMS. The study will monitor changes in depression symptoms over a period of six weeks, with follow-up assessments at six months to evaluate the long-term effects of the treatment.

Throughout the study, participants will be asked to complete various questionnaires and tests to assess their mood, anxiety levels, and cognitive performance. These assessments will help researchers understand the impact of the treatment on different aspects of mental health. The study aims to provide valuable insights into improving treatment options for individuals with Major Depressive Disorder.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be assessed to confirm your eligibility. This includes verifying that you have a primary diagnosis of major depressive disorder (MDD) with a current moderate to severe depressive episode, are aged between 18-65 years, and have tried at least two types of antidepressant medication without sufficient results.
Step 2
Treatment day
On the treatment day, you will receive a single session of accelerated transcranial magnetic stimulation (TMS). This is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain.
You will also be administered D-cycloserine (DCS) in the form of a hard capsule. The dosage and specific instructions for taking this medication will be provided by the study team.
Step 3
Post-treatment monitoring
After the treatment, your progress will be monitored weekly for six weeks. This involves measuring the percentage reduction from your baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score.
You will also complete a side effect questionnaire immediately after the treatment to report any adverse effects you may experience.
Step 4
Follow-up assessments
At six weeks post-treatment, your clinical remission and response will be evaluated. Clinical remission is defined as a MADRS score of 8 or less, and clinical response is a reduction from baseline MADRS score of more than 50%.
You will also complete an EQ5D questionnaire at this time to assess your overall health status.
Step 5
Extended follow-up
Your progress will continue to be monitored monthly for the remainder of six months. This includes measuring the percentage reduction from baseline scores on the Generalized Anxiety Disorder 7-item (GAD-7) scale and the Patient Health Questionnaire-9 (PHQ-9).
At six months, a final assessment will be conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

3 criteria

A primary diagnosis of Major Depressive Disorder (MDD), with a current moderate to severe depressive episode. This means a score of more than 20 on a specific depression rating scale called the MADRS.
Age between 18-65 years old.
A diagnosis of moderate to severe treatment-resistant depression (TRD). This means you have tried at least 2 types of antidepressant medication without getting enough relief.

Who cannot join the trial?

8 criteria

Patients with any other psychiatric disorder besides Major Depressive Disorder (MDD) cannot participate. This means if you have another mental health condition, you may not be eligible.
Patients who have a history of seizures or epilepsy cannot participate. Seizures are sudden, uncontrolled electrical disturbances in the brain.
Patients with metal implants in the head, except for dental fillings, cannot participate. Metal implants can interfere with the study equipment.
Patients who are currently using medications that affect the brain and cannot be safely stopped for the study duration cannot participate. This includes certain antidepressants or antipsychotics.
Patients with a history of substance abuse or dependence within the past year cannot participate. Substance abuse refers to the harmful use of substances like alcohol or drugs.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the child.
Patients with unstable medical conditions cannot participate. An unstable condition is one that is not well-controlled or is changing rapidly.
Patients who have participated in another clinical trial within the last 30 days cannot participate. This is to avoid interference between studies.

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University Hospital Maastricht
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Maastricht, The Netherlands

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Investigated drugs

D-cycloserine
is a medication that is being studied for its potential to enhance the effects of transcranial magnetic stimulation (TMS) in treating depression. It is thought to work by affecting certain brain chemicals that are involved in mood regulation. In this trial, D-cycloserine is used to see if it can make TMS more effective in reducing symptoms of depression.
Transcranial Magnetic Stimulation (TMS)
is a non-invasive therapy that uses magnetic fields to stimulate nerve cells in the brain. It is used to treat depression, especially in cases where other treatments have not been effective. In this trial, TMS is being used in an accelerated form, meaning the sessions are more frequent, to see if it can quickly reduce depressive symptoms when combined with D-cycloserine.

What is already known about the treatment

D-cycloserine – D-cycloserine is taken orally in pill form and is being studied for its potential to help treat Major Depressive Disorder (MDD) by enhancing the effects of transcranial magnetic stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain. Currently, D-cycloserine is not widely used for depression, but it is being researched for this purpose. It works by affecting certain receptors in the brain that are involved in mood regulation, potentially making TMS more effective. D-cycloserine is classified as an antibiotic, but in this context, it is being explored for its neurological effects.

Investigated diseases

Major Depressive Disorder (MDD) – 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 affects how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The disorder can lead to a variety of emotional and physical problems, making it difficult for individuals to function at work and in their personal lives. Symptoms may include changes in appetite or weight, sleep disturbances, fatigue, and difficulty concentrating. The progression of MDD can vary, with some individuals experiencing episodes that last for weeks or months, while others may have recurrent episodes throughout their lives. The severity and duration of symptoms can differ from person to person.