Using transcranial alternating current stimulation to study serotonin receptors in depression

Effect of Transcranial Alternating Current Stimulation (tACS) on Serotonin-1A Receptor in Patients With Major Depressive Disorder

This study is testing whether a brain stimulation technique can help improve symptoms of depression by looking at how it affects a specific serotonin receptor in people with major depressive disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06211140 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial alternating current stimulation (tACS) on the serotonergic system, specifically the Serotonin-1A (5-HT1A) receptor, in patients with major depressive disorder. It employs a multimodal approach that includes neuroimaging techniques such as 18F-MPPF PET/MR, psychological evaluations, and sleep monitoring to explore the neurobiological mechanisms of tACS. The study aims to determine how tACS may influence the 5-HT1A receptor and functional connectivity in the brain, potentially leading to improvements in depressive symptoms. Participants will undergo assessments before and after the tACS intervention to evaluate changes in their condition.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 to 65 with non-psychotic major depressive disorder experiencing an acute episode.

Not a fit: Patients with secondary insomnia, anxiety disorders, or those with severe organic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights into the treatment of major depressive disorder by enhancing understanding of the serotonergic system and improving therapeutic approaches.

How similar studies have performed: While the use of tACS in depression is a relatively novel approach, previous studies have shown promising results with similar techniques in improving depressive symptoms.

Eligibility criteria

Inclusive Criteria:

1. 18 to 65 years old, Chinese, male or female.
2. Non-psychotic major depressive disorder according to DSM-IV.
3. HAMD-17 total score ≥ 17 at the baseline.
4. Currently experiencing an acute episode.
5. No history of prior treatment with psychotropic medications.
6. Understanding of all aspects of the research protocol and the ability to provide informed consent.

Exclusion Criteria for patients:

1. Unable to do PET/MR examinations.
2. Have secondary insomnia disorders, anxiety disorders, or depressive disorders caused by physical illnesses.
3. Severe or unstable organic diseases.
4. Pregnant or lactating women or those planning a pregnancy in the near future.
5. Alcohol or substance dependence or abuse within the past year.
6. Received electroconvulsive therapy or transcranial magnetic stimulation in the month preceding enrollment.
7. Skin damage at the electrode placement site or those allergic to electrode gel or adhesives.
8. Participated in any other clinical trials within the month before baseline.
9. Any inappropriate conditions considered by the study group.

Inclusion Criteria for healthy volunteers

1. To undergo PET/MR examinations.
2. Be matched with the patient group regarding age, sex, and educational level.

Exclusion Criteria for healthy volunteers:

1. Those who are enrolled in other clinical studies.
2. The inappropriate conditions considered by the study group.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Wenfeng Zhao, MD

Conditions Major Depressive Disorder; Depression; tACS; 5-HT