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

NCT04685642 | Unknown Phase 4

• 1 other identifier: 109-2314-B-010 -050 -MY3
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mood Disorder

Keywords

Anti-inflammatory treatment; depression; bipolar disorder; telomere length; brain imaging

Outcome Measures

Primary Outcomes (1)

• Reduction rate the clinical symptoms after original treatment combined aspirin or atorvastatin.

  Treatment Efficacy

  baseline, week 4, week 8, week 12

Secondary Outcomes (2)

• The T1-weight

  Once on baseline.

• The resting fMRI

  Once on baseline.

Study Arms (3)

non-drug

NO INTERVENTION

Aspirin

ACTIVE COMPARATOR

Drug: Aspirin

Statin

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

Aspirin DRUG

Aspirin (100mg/day)

Aspirin

Atorvastatin DRUG

Atorvastatin (20mg/day)

Statin

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 to 65 years old.
• 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.
• Maintain psychiatric medication for more than three months.
• Voluntary patients and controls with signed informed consent proved by institutional review board (IRB).

You may not qualify if:

• Patients have used aspirin, statin previously .
• Patients have gastrointestinal disease, history of gastrointestinal bleeding, hematology coagulation disease, sever liver and renal disease.
• Patients with schizophrenia, organic brain diseases, mental retardation.
• Patients with symptoms of substance abuse/dependence (except nicotine dependence) within 3 months.
• Patients with autoimmune, acute infection and critical medical illnesses .
• Patients who cannot cooperate the study protocol.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Depression; Bipolar Disorder

Interventions

Aspirin; Atorvastatin

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ya Mei Bai, M.D. Ph.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya Mei Bai, M.D. Ph.D.

CONTACT

886-2-28757027; ymbi@mail2000.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 28, 2020
• Study Start: August 24, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

TW (1)