TMSxDCS: Medicinal improvement of brain stimulation for depression.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universiteit Maastricht

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2025-06-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Maastricht University Medical Center (MUMC+)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The primary objective of this study is to investigate the antidepressive effect of augmenting a single day of accelerated transcranial magnetic stimulation (TMS) with D-cycloserine (DCS).

Secondary objectives 7

1. A secondary objective of this study is to investigate the durability of the antidepressive response at 6 months follow-up.
2. A secondary objective of this study is to investigate the clinical outcomes of augmenting a single day of aTMS with DCS.
3. A secondary objective of this study is to investigate the anxiolytic effect of augmenting a single day of aTMS with DCS.
4. A secondary objective of this study is to investigate the antidepressive effect of augmenting a single day of aTMS with DCS according to self-report.
5. A secondary objective of this study is to investigate the effect of TMSxDCS on cognitive outcomes.
6. A secondary objective of this study is to assess the adverse events of augmenting a single day of aTMS with DCS.
7. A secondary objective of this study is to assess the change in quality of life at 6 weeks follow-up.

Conditions and MedDRA coding

Major Depressive Disorder (MDD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. A primary diagnosis of MDD, with a current moderate to severe depressive episode (score of >20 on the MADRS)
2. Age between 18-65 years old
3. A diagnosis of moderate to severe measures of treatment resistant depression (TRD) and have tried at least 2 types of antidepressant medication without sufficient result

Exclusion criteria 12

1. Any change in antidepressant treatment (medication, psychotherapy) 4 weeks prior to enrollment
2. Primary psychiatric diagnosis other than MDD
3. A history of bipolar disorder
4. A history of psychosis
5. A history of schizophrenia
6. A history of renal insufficiency
7. Current substance abuse disorder
8. Current scheduled use of benzodiazepines (as needed use is permitted, except for the day prior to treatment)
9. Current use of any of the following medications: Olanzapine, clozapine, ethionamide, isoniazid
10. Has a cochlear implant
11. Metal implants near (<10 cm away from coil) the head including: - Aneurysm clips / coils - Any medical implant containing metal near the head - Metal stents in the brain - Shrapnel or bullet fragments - Implanted vagus nerve or deep brain stimulators, Electrodes for monitoring brain activity
12. Pregnancy upon inclusion or during the study period, though women with childbearing potential will be included into the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage reduction from baseline MADRS score measured weekly for 6 weeks post-treatment

Secondary endpoints 7

1. Percentage reduction from baseline MADRS-score at 6 months follow-up.
2. Clinical remission (defined as a MADRS-score of ≤8) and clinical response (defined as a reduction from baseline MADRS score of >50%) at 6 weeks follow-up.
3. Percentage reduction from baseline GAD-7-score measured weekly for the first 6 weeks post-treatment and monthly for the remainder of 6 months.
4. Percentage reduction from baseline PHQ-9-score measured weekly for the first 6 weeks post-treatment and monthly for the remainder of 6 months.
5. Change in performance on the cognitive test battery at 1 week follow-up.
6. Side effect questionnaire taken immediately after treatment.
7. EQ5D questionnaire taken at 6 weeks follow-up.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universiteit Maastricht

Sponsor organisation

Universiteit Maastricht

Address

P. O. Box 616

City

Maastricht

Postcode

6200 MD

Country

Netherlands

Scientific contact point

Organisation

Universiteit Maastricht

Contact name

Bart Rutten

Public contact point

Organisation

Universiteit Maastricht

Contact name

Koen Augustijn

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications