NCT06534684 The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
| NCT ID | NCT06534684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of North Norway |
| Condition | Depression, Unipolar |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-12 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-02-12 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.
Eligibility Criteria
Inclusion criteria: * Patients must meet the diagnostic criteria of at least a moderate depression * The duration of the current depressive episode must have lasted more than 2 weeks but less than 2 years * Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS * Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI Exclusion criteria: * The current depressive episode is in the mild range * The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy, * The current depressive episode is clearly triggered by grief or a recent major stressful life event * Bipolar disorder * Borderline personality disorder * Psychotic symptoms * Alcohol or substance abuse/addiction in the last 6 months * Current eating disorders * Obsessive- compulsive disorders * Post-traumatic stress disorder * A life-time medical history of seizure * Neurological or neurosurgical pathologies * Cardiac or systemic disease * Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.) * Autism * Pregnancy * Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06534684 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 65 Years, studying Depression, Unipolar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06534684 currently recruiting?
Yes, NCT06534684 is actively recruiting participants. Contact the research team at per.aslaksen@unn.no for enrollment information.
Where is the NCT06534684 trial being conducted?
This trial is being conducted at Tromsø, Norway.
Who is sponsoring the NCT06534684 clinical trial?
NCT06534684 is sponsored by University Hospital of North Norway. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.