NCT05913960Recruiting
Accelerated Intermittent Theta-Burst Stimulation Ameliorate Major Depressive Disorder by Regulating CAMKII Pathway
the Mechanism of Accelerated Intermittent Theta Burst Stimulation for Rapid Treatment of Major Depressive Disorder Based on the Prefrontal Excitation-inhibition Balance Regulated by CAMKII Pathway
Source: ClinicalTrials.gov · Last updated 22 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Major depressive disorder(MDD) is a complex and heterogeneous mental disorder. Repeated transcranial magnetic stimulation (rTMS), as a non-invasive neuroregulatory technique, has shown a promising function in the treatment of depression. Theta-burst transcranial magnetic stimulation (TBS) model significantly shortened the duration of physical therapy treatment, and iTBS under the accelerated model (The latter is referred to as aiTBS)showed promising therapeutic effect. However, whether aiTBS has a better and faster curative effect in the first untreated or recurrent unmedicated MDD patients and the mechanism of its alleviation of depressive symptoms remains unclarified. This project intends to verify changes in CAMKII levels, CAMKII molecules and GABA receptors in brain-derived exosomes in normal controls and patients who received sham, aiTBS and high-frequency (10Hz) stimulation respectively. Neuroimaging and TMS-EEG were used to pinpoint the target of stimulation and to record the changes of brain waves before and after treatment in real time. To clarify the neurobiological mechanism of aiTBS rapidly improving depression, and to provide a new strong evidence for clinical transcranial magnetic stimulation for accurate treatment of MDD patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 16 Mar 2023
- Start date
- 9 Feb 2023
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Depression
- NCT number
- NCT05913960
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 9 Feb 2023 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol and drug dependence or is being treated for a hormone drugs patients;
Other illness
- Other organic mental disorders and mental retardation and other severe mental disorders;
- Infection, trauma, and autoimmune diseases or other possible interference test evaluation of disease;
- Seizure or a family history of epilepsy;
Other
- Craniocerebral injury;
- Pregnancy and lactation women;
- All landowners had a metal and MRI contraindications or MRI examination revealed abnormal brain structure.
Who the study is looking for
- Sign a written informed consent to participate in the trial and receive treatment;
- Major depressive disorder diagnosis;
- Hamilton depression scale (HAMD - 24) 24 total score 20 points or more;
- First episode or recurrence of depression patients, not taking psychiatric drugs;
- The han nationality, right-handed;
- Junior high school or above;
Age in the registry: 12 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.