Anti-inflmmation Treatment in Mood Disorder and Deep Learning Prediction Model

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This three-year study will enroll 180 patients with mood disorders (90 patients with major depressive disorder and 90 patients with bipolar disorder) and high pro-inflammatory cytokine levels. They will be randomly assigned to three groups of aspirin, statin and control groups for 12 weeks according to the disease group. The first aim of the study is to compare the efficacy of aspirin and statin in mood disorders. The second aim is to establish a gene-immuno-brain imaging treatment prediction model by deep learning technology, using pretreatment cytokines, neurocognitive function, brain structural/functional connectivity, and telomere length as the predictors.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Aspirin; Atorvastatin

Criteria

Inclusion Criteria:

1. Age between 20 to 65 years old.

2. The baseline pro-inflammatory cytokines level: soluble IL6 receptor (sIL-6)>35,000pg/ml, or CRP>1,500ng/ml, or sTNF-R1>1,000pg/ml.

3. Maintain psychiatric medication for more than three months.

4. Voluntary patients and controls with signed informed consent proved by institutional review board (IRB).

Exclusion Criteria:

1. Patients have used aspirin, statin previously .

2. Patients have gastrointestinal disease, history of gastrointestinal bleeding, hematology coagulation disease, sever liver and renal disease.

3. Patients with schizophrenia, organic brain diseases, mental retardation.

4. Patients with symptoms of substance abuse/dependence (except nicotine dependence) within 3 months.

5. Patients with autoimmune, acute infection and critical medical illnesses .

6. Patients who cannot cooperate the study protocol.