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

NCT ID: NCT04685642

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-24

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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Multiple lines of evidence support the pathogenic role of neuro-inflammation in mood disorders. Our team has published a series of papers showing the inflammatory cytokines are related to severity of depressive symptoms, could be biomarkers of clinical outcomes, subtype and mood phase of bipolar disorder. Compared with depressive disorder, bipolar disorder is with more severe inflammatory dysregulation, which correlated to brain structure and functional connectivity abnormality. Treatment non-responders tended to have higher baseline inflammatory markers, suggesting that increased levels of inflammation are contributory to treatment resistance. The clinical studies showed that anti-inflammatory drugs combined with traditional treatments, can improve clinical outcomes, including N-Acetylcysteine, infliximab, pioglitazone, celecoxib, aspirin, omega-3 polyunsaturated fatty acids, minocyclin, statin, aspirin. Among them, aspirin and statin have been used for treatment and prevention of cardiovascular metabolic disorders, which are associated with inflammation dysregulation. The clinical and meta-analysis studies of aspirin and statin have shown significant efficacy and good safety. Therefore, aspirin and statin have better clinical feasibility and rationality for augmentation treatment in mood disorders. However, previous anti-inflammatory research is mostly for individual drug studies, comparative research is still quite lacking. In addition, many studies have suggested anti-inflammatory agents will likely be most useful for the subpopulation of patients whose immune dysfunction is a driving pathogenic factor.

In this study, we will establish a prediction model of anti-inflammatory drugs for mood disorder. Recent advances in deep learning have demonstrated its power to learn and recognize complex nonlinear hierarchical patterns based on largescale empirical data. A deep learning algorithm for classification applications such as medical treatment in personalized medicine is a procedure for choosing the best hypothesis from a set of alternatives that fit a set of observations. Our series of studies have shown that the severity of inflammation related with brain structure and functional connectivity abnormalities; which may be the outcome predictors. Another possible predictor may be the chromosome telomere length. Telomeres are located at the end of chromosomes and maintain normal function of chromosomes. Previous studies have found that short telomere length is associated with mood disorder, as well as the inflammatory dysregulation. Therefore, telomere length may be a predictor of anti-inflammatory treatment. The study will be the first comparative study of anti-inflammatory treatment, and establish gene-immuno-brain imaging individualized treatment prediction model. The results will provide important scientific and clinical empirical data for the inflammatory pathophysiology and treatment of mood disorders.

Conditions

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Mood Disorder

Keywords

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Anti-inflammatory treatment depression bipolar disorder telomere length brain imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-drug

Group Type NO_INTERVENTION

No interventions assigned to this group

Aspirin

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin (100mg/day)

Statin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Atorvastatin (20mg/day)

Interventions

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Aspirin

Aspirin (100mg/day)

Intervention Type DRUG

Atorvastatin

Atorvastatin (20mg/day)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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

Role: CONTACT

Phone: 886-2-28757027

Email: [email protected]

Facility Contacts

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YA-MEI BAI, PhD

Role: primary

Other Identifiers

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109-2314-B-010 -050 -MY3

Identifier Type: -

Identifier Source: org_study_id