Personalizing antidepressant treatment for major depression

Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module in Multidimensional Omics for Peripheral Biomarkers.

This study is trying to find better ways to choose antidepressants for people with major depression by looking at their unique biological traits to improve treatment results.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04518592 on ClinicalTrials.gov

What this trial studies

This study aims to identify clinical subtypes and biological markers of Major Depressive Disorder (MDD) to tailor antidepressant treatments. By integrating various omics data, including genomic and metabolic information, the researchers will develop predictive models to enhance treatment outcomes. The goal is to reduce the reliance on trial-and-error approaches in medication selection, ultimately improving patient experiences and lowering healthcare costs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who meet the criteria for severe Major Depressive Disorder and have significant depressive symptoms.

Not a fit: Patients with other mental disorders or those at high risk for suicidal behavior may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with major depression.

How similar studies have performed: While there have been studies exploring personalized treatment approaches in depression, this specific integration of multidimensional omics data is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects aged 18-65 years, outpatients or inpatients.
2. Meets the DSM-V criteria for Severe Major Depressive Disorder ; a single episode（296.21、296.22、296.23）or recurrent episode （296.31、296.32、296.33）；
3. MADRS score greater than or equal to 24 in baseline；
4. HAMD-17 score greater than or equal to 20 in baseline.
5. Patients have learned and voluntarily participated in the study, and have to sign informed consent.

Exclusion Criteria:

1. Meets the DSM-V criteria for other mental disorder(schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc ).
2. Patient has survived suicide attempt , or may have a significant risk for suicidal behavior ,or with a score of \>3 on suicidal thoughts item 10 on the MADRS.
3. Depressive episode of an organic mental disorder secondary to a systemic disease or a central nervous system disease, such as depressive episode secondary to hypothyroidism.
4. Serious and instable body disease such as cerebrovascular disease, respiratory disease, blood disease, liver and kidney disease, disease of internal secretion, nervous system and other systemic disease.
5. any history of seizures or other organic brain diseases.
6. History of alcohol or drug abuse (besides nicotine) over the last 6 months
7. Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
8. Subjects who can't take drug or have an operation history which affect drug metabolism.
9. Clinically significant changes in ECG or laboratory tests, including \>1.5X upper limit of normal liver function、over the limit of normal renal function and blood sugar、abnormal cardiac troponins、obvious abnormity in the thyroid function
10. Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within three months;
11. Participation in other clinical studies in the nearly 1 month before screen.
12. Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Where this trial is running

Shanghai, Shanghai

• Shanghai Mental Health Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: huafang Li, Phd

Conditions Major Depressive Disorder