Using iTBS to treat depression in bipolar II disorder
Changes in Serum miRNA and BDNF Levels in Bipolar II Depression Treated by Theta-burst Stimulation: A Randomized Sham-controlled Exploratory Study
This study is testing if a new brain stimulation treatment called iTBS can help people with bipolar II disorder who are feeling very depressed feel better faster than a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Kaohsiung Veterans General Hospital. Academic / other |
| Locations | 1 site (Kaohsiung city) |
| Trial ID | NCT04998097 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intermittent theta-burst stimulation (iTBS) as a treatment for patients with bipolar II disorder experiencing a major depressive episode. It aims to compare the antidepressant effects of iTBS against a sham treatment in a randomized, controlled design involving 60 participants aged 20 to 65. Participants will receive 10 sessions of iTBS over two weeks while on quetiapine monotherapy, with evaluations conducted by research psychiatrists to assess mood symptoms. The study seeks to provide evidence for a potentially faster and more effective treatment option for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-65 with a confirmed diagnosis of bipolar II disorder currently in a depressive state.
Not a fit: Patients with other major mental illnesses, significant medical or neurological disorders, or those with a history of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a quicker and more effective option for managing depression in patients with bipolar II disorder.
How similar studies have performed: While the antidepressant effects of iTBS for major depressive disorder are well established, its application for bipolar II depression is still under investigation, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The Chinese Version of Modified Schedule of Affective Disorder and Schizophrenia-Life Time (SADS-L) and DSM-IV-TR will be conducted for confirmation of the diagnosis of BD-II. 2. Aged 20-65. 3. HDRS and YMRS will be used to evaluate severity of mood symptoms. Only patients in deressive state (HDRS≧18) will be recruited. Exclusion Criteria: 1. Any DSM-IV-TR Axis I diagnosis, including organic mental disorders, substance use disorder, and other major and minor mental illnesses other than BD-II. 2. Any significant medical illness. 3. Any neurological disorders. 4. Any poorly controlled physical illness that might influence the interview and study results. 5. Any form of metal implants. 6. Any history of seizures, or medications known to lower seizure threshold. 7. History of exposure to TMS or electroconvulsive therapy.
Where this trial is running
Kaohsiung city
- KaohsiungVGH — Kaohsiung city, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.