Bipolar II Disorder, Most Recent Episode Major Depressive Clinical Trial
Official title:
Changes in Serum miRNA and BDNF Levels in Bipolar II Depression Treated by Theta-burst Stimulation: A Randomized Sham-controlled Exploratory Study
Verified date | October 2023 |
Source | Kaohsiung Veterans General Hospital. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There is a paucity of evidence-supported treatment choices for bipolar II depression (BD-II depression), hindered by multiple comorbidity and manic switch. In addition, a slower response also burdens the patients. Intermittent theta-burst stimulation (iTBS) is a new form of Repetitive transcranial magnetic stimulation (rTMS) which is more powerful and requires less time of operation (i.e., about 1/3 of traditional treatment time) compared to traditional rTMS protocols. The antidepressant effect of iTBS for major depressive disorder is well established; however, its effect for BD-II depression is still undetermined with few investigations. In the current study, the investigators plan to conduct a randomized, controlled study to directly compare antidepressant effects of iTBS (n=30) versus sham (n=30) for BD-II depression under treatment of quetiapine monotherapy. The participants will receive 10 times of iTBS sessions in 2 weeks (daily from Monday to Friday and off on the weekends for 2 weeks), followed on the end of week 2 (right after treatment,), week 6 and week 12. The investigators hypothesize that iTBS is effective for BD-II depression and may improve cognitive decline associated with BD-II. In addition, the investigators have identified several microRNAs (miRNAs) (miR-7-5p, miR-142-3p, miR-221-5p, and miR-370-3p) which may aid the diagnosis of BD-II and such diagnostic model was patented in Taiwan. The investigators further found significant correlations with these miRNAs with peripheral levels of brain derived neurotrophic factor (BDNF). The investigators inferred that these miRNAs may be associated with susceptibility with BD-II thru modulation of BDNF. Because modulation of BDNF level is one of the anti-depression mechanism for rTMS, the investigators plan to monitor the changes of these candidate miRNAs and BDNF levels in serum before and after iTBS treatment (week 0, 2,6,12), in attempt to clarify whether these miRNAs may be treatment biomarker as well. The investigators believe that the current study result may be a great addition for predictor for therapeutic assessment and precision treatment of BD-II depression.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | KaohsiungVGH | Kaohsiung city |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Veterans General Hospital. |
Taiwan,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Brief Assessment of Cognition in Affective Disorders (BACA) | The BACA is used to evaluate objective cognitive functioning in patients with mood disorders. A T-score of 50 demonstrates average functioning with regard to the healthy population with the same age and gender; the standard deviation is 10 points. | Baseline, endpoint (week 12) | |
Other | plasma miRNA | The following plasma miRNA levels: miR-7-5-p, miR-142-3p, miR-370-3p, miR221-5p (miRNA unit: delta Ct). | Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint). | |
Other | plasma BDNF level | Plasma BDNF levels. | Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint). | |
Primary | Hamilton Depression Rating Scale (HDRS) | Clinical depression severity will be assessed by the HDRS. The total score range is from 0 to 52. Higher scores (>=18) indicate a greater degree of depression. A significant change in the score is considered a response to rTMS. HDRS will be assessed from baseline, week2, week 6,and week12. | Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint). | |
Secondary | Young Mania Rating Scale (YMRS) | Clinical manic severity will be assessed by the YMRS. The total score range is from 0 to 44. Higher scores (>29) indicate a greater degree of maina. YMRS will be used to assess mood severity at baseline, week2, week6,and week12.. | Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00475137 -
Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression
|
Phase 2 | |
Recruiting |
NCT05849402 -
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
|
N/A |