Status:
TERMINATED
Combining rTMS and tDCS in Depression: an Exploratory Clinical Trial
Lead Sponsor:
Regionspsykiatrien Gødstrup
Conditions:
Major Depression
Treatment Resistant Depression
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief Summary
The investigators aim to conduct a single-arm open-label clinical trial, meaning that the investigators will be administering a treatment protocol to one group of patients, where no information is wit...
Eligibility Criteria
Inclusion
- Male or female, between 22 and 80 years of age.
- Able to provide informed consent.
- Primary diagnosis of depressive episode (F32) or recurrent depressive disorder (F33), according to International Classification of Diseases 10th Revision (ICD-10).
- Simultaneous fulfillment of diagnostic criteria for Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE), according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Currently experiencing moderate to severe depressive episodes (scores ≥20 on the 17-item Hamilton Depression Rating Scale \[HAM-D 17\]).
Exclusion
- Primary psychiatric diagnosis other than single episode depressive disorder or recurrent depressive disorder.
- History of schizophrenia or schizoaffective disorders.
- Any history of psychotic symptoms in the current or previous depressive episodes.
- History of obsessive-compulsive disorder.
- History of autism spectrum disorder.
- History of intractable migraine.
- Clinical conditions that would increase risks associated with receiving high-dose iTBS.
- Cochlear implants.
- Epilepsy.
- Pacemakers.
- Presence of metal in the head, especially of a ferromagnetic type.
- Presence of magnetically controlled implantable devices.
- Current drug misuse (F10-F19).
- History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
- Current (or chronic) use of opiates.
- Prior nonresponse to rTMS.
- Prior nonresponse to Electroconvulsive Therapy (ECT).
- Female that is pregnant or breastfeeding.
- Female with a positive pregnancy test at participation.
- History of psychosurgery for depression.
- Damage to- or diseases of the skin, which affects the scalp. E.g. Psoriasis or open wounds.
- No changes in psychotropic medication during the study will be allowed, with the exception of the ones due to intolerability.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06500533
Start Date
July 31 2024
End Date
May 19 2025
Last Update
May 23 2025
Active Locations (1)
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1
Regionspsykiatrien Gødstrup
Herning, Central Jutland, Denmark, 7400