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Study of D-cycloserine with theta-burst brain stimulation for adults with major depressive disorder

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This study focuses on treating patients with Major Depressive Disorder, a serious mental health condition characterized by persistent feelings of sadness and loss of interest in daily activities. The research combines two treatments: a technique called accelerated intermittent theta-burst stimulation (a form of brain stimulation) and D-cycloserine, a medication given as oral capsules.

The study aims to determine if adding daily 100 mg D-cycloserine capsules improves the effectiveness of brain stimulation treatment compared to a placebo in reducing depression symptoms. The treatment period lasts for nine weekdays, during which participants receive both brain stimulation and either the medication or placebo capsules. The placebo capsules look identical to the real medication but contain an inactive substance.

Participants will be monitored for changes in their depression symptoms through various assessments over a period of 180 days. The study includes regular check-ups to evaluate mood, anxiety levels, daily functioning, and overall well-being. Throughout the study, participants will take either D-cycloserine or placebo capsules, but neither the participants nor the healthcare providers will know which one they are receiving until the study is complete.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your depression symptoms will be evaluated using a special rating scale called MADRS (Montgomery-Asberg Depression Rating Scale) to confirm if you meet the study criteria.
You must have experienced depression symptoms for at least 30 days and have a MADRS score of 20 or higher.
Your current medications will be reviewed - they must remain unchanged for 4 weeks before and during the first 28 days of the study.
Step 2
Treatment phase
The treatment will last for nine weekdays.
You will receive either 100 mg of D-cycloserine or a placebo (inactive capsule) daily.
The placebo capsule looks identical to the medication - it is orange in color and contains harmless cellulose.
You will also receive a treatment called aiTBS (accelerated intermittent theta-burst stimulation) during this period.
Step 3
Follow-up assessments
Your depression symptoms will be evaluated through video consultation at day 28.
Additional assessments will occur on days 12, 42, and 180.
The evaluations will include:
- Depression symptoms assessment
- Anxiety symptoms check
- General health evaluation
- Cognitive function testing
- Brain activity measurements
Step 4
Study completion
The final evaluation will take place on day 180.
Your participation in the study will end after completing all required assessments.
The total duration of your participation will be 180 days from the start of treatment.

Who can join the trial?

10 criteria

Must provide written consent to participate in the trial
Must be at least 18 years old when providing written consent
Female participants who can become pregnant must use adequate contraception
Must be able to read, speak, and understand Swedish
Must be able and willing to attend all study visits, including preparation sessions, follow-up appointments, and complete all study evaluations
Must be able to swallow capsules
Must have been diagnosed with major depressive disorder and currently experiencing a depressive episode lasting at least 30 days at screening time
Must have moderate to severe depression symptoms at screening, shown by a MADRS score of 20 or higher (MADRS is a scale used to measure depression severity)
Must have tried at least one standard antidepressant medication or psychotherapy without achieving satisfactory results
Must have been on the same antidepressant medications for at least 4 weeks before joining the study and must not plan to change medications during the first 28 days of the study

Who cannot join the trial?

15 criteria

Age below 18 years
Presence of psychotic symptoms (loss of touch with reality, including hallucinations or delusions)
History of seizures or epilepsy
Having metal objects in the head area (except for dental fillings)
Pregnancy or breastfeeding
Current use of specific medications that could interact with study treatment
Substance abuse (alcohol or drug dependency) within the past 6 months
Participation in other clinical trials within the past 30 days
Severe neurological conditions or brain injuries
Unstable medical conditions that require immediate treatment
History of not responding to depression treatments in the past
Having thoughts of self-harm that require immediate intervention
Inability to provide informed consent
Severe allergic reactions to medications similar to the study drug
Significant changes in psychiatric medications within the past 4 weeks

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Verified sites

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
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Region Skane Skanes Universitetssjukhus
Lund, Sweden
Verified
Uppsala University Hospital
Uppsala, Sweden

Trial locations

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Investigated drugs

D-cycloserine
This is an oral medication that works in the brain to help treat major depressive disorder. It is being studied as an add-on treatment to enhance the effects of brain stimulation therapy in people with depression.
Accelerated intermittent theta-burst stimulation (aiTBS)
This is a non-invasive brain stimulation therapy that uses magnetic pulses to stimulate specific areas of the brain. It is delivered over nine weekdays and is designed to help improve symptoms of depression. This is a newer, faster version of traditional brain stimulation treatment.

What is already known about the treatment

D-cycloserine - An oral medication administered in tablet form that acts as a partial agonist at the glycine binding site of N-methyl-D-aspartate (NMDA) receptors in the brain. Originally developed as an antibiotic for tuberculosis treatment, it is now being studied in clinical trials for major depressive disorder (MDD) due to its potential to enhance neuroplasticity and improve the effectiveness of brain stimulation treatments. When used in combination with accelerated intermittent theta-burst stimulation (aiTBS), it may help modify neural pathways involved in depression, with current research exploring a daily dose of 100mg for treating severe depressive symptoms.

Investigated diseases

Major Depressive Disorder (MDD) - A mental health condition characterized by persistent feelings of sadness, loss of interest in activities, and decreased energy lasting for at least two weeks. The condition affects a person's thoughts, feelings, behavior, and physical well-being, often causing changes in sleep patterns, appetite, and concentration. People with MDD may experience recurring episodes of depression throughout their lives, with symptoms varying in intensity and duration. The condition can affect daily functioning, including work, social relationships, and overall quality of life. During depressive episodes, individuals may feel worthless, have difficulty making decisions, or experience changes in their activity levels.