Mood DisorderPhase 4NCT04685642
Anti-inflmmation Treatment in Mood Disorder and Deep Learning Prediction Model
A Phase 4 study testing Aspirin and Atorvastatin in people with Mood Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Mood Disorder
- What is being tested?
- Aspirin and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2020to 31 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
YA-MEI BAI, PhD, 28757027 ext. 201, ymbai@vghtpe.gov.tw
About this study
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.
Read the detailed description
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
- Mood Disorder
- Being tested
- Aspirin, Atorvastatin
- Keywords
- Anti-inflammatory treatment, depression, bipolar disorder, telomere length, brain imaging
- Medical subject headings
- Mood Disorders, Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin (100mg/day)
AtorvastatinDrug
Atorvastatin (20mg/day)
| Study group | Role | What they receive |
|---|---|---|
| non-drug | No intervention | Not described |
| Aspirin | Active comparator | Not described Receives: Drug: Aspirin |
| Statin | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction rate the clinical symptoms after original treatment combined aspirin or atorvastatin.
Treatment Efficacy
Measured: baseline, week 4, week 8, week 12
Secondary outcomes (2)
The T1-weight
The T1-weight will be taken on a 3T MR scanner (Discovery 750, GE).
Measured: Once on baseline.
The resting fMRI
The resting fMRI will be taken on a 3T MR scanner (Discovery 750, GE).
Measured: Once on baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start24 Aug 2020
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ya Mei Bai, M.D. Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685642
- Sponsor's protocol ID
- 109-2314-B-010 -050 -MY3
- Status last verified
- Dec 2020
- First submitted
- 6 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflmmation Treatment in Mood Disorder and Deep Learning Prediction Model
- ClinicalTrials.gov ID
- NCT04685642
- Acronym / sponsor ID
- 109-2314-B-010 -050 -MY3
- Conditions
- Mood Disorder
- Keywords
- Anti-inflammatory treatment, depression, bipolar disorder, telomere length, brain imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-drug | No intervention | – |
| Aspirin | Active comparator | Drug: Aspirin |
| Statin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin (100mg/day) | Drug | Aspirin |
| AtorvastatinAtorvastatin (20mg/day) | Drug | Statin |
Primary outcome
Reduction rate the clinical symptoms after original treatment combined aspirin or atorvastatin.
Time frame: baseline, week 4, week 8, week 12
Treatment Efficacy
2 secondary outcomes
The T1-weight
Time frame: Once on baseline.
The resting fMRI
Time frame: Once on baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya Mei Bai, M.D. Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Atorvastatin in people with Mood Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya Mei Bai, M.D. Ph.D. (886-2-28757027 ext. 279, ymbi@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction rate the clinical symptoms after original treatment combined aspirin or atorvastatin. (time frame: baseline, week 4, week 8, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.