Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module.

Last updated: April 19, 2024
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Depression (Adult And Geriatric)

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT04518592
MDSDOT
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.

Eligibility Criteria

Inclusion

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 singleepisode(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 signinformed consent.

Exclusion

Exclusion Criteria:

  1. Meets the DSM-V criteria for other mental disorder(schizophrenia spectrum and otherpsychotic 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 suicidalbehavior ,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 acentral nervous system disease, such as depressive episode secondary tohypothyroidism.
  4. Serious and instable body disease such as cerebrovascular disease, respiratorydisease, 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 kidneydisease, disease of internal secretion (abnormal thyroid function), blood disease; anyhistory of seizures or other organic brain diseases.
  8. Subjects who can't take drug or have an operation history which affect drugmetabolism.
  9. Clinically significant changes in ECG or laboratory tests, including >1.5X upper limitof normal liver function、over the limit of normal renal function and bloodsugar、abnormal cardiac troponins、obvious abnormity in the thyroid function
  10. Pregnant or lactating women and women of childbearing potential throughout the studyperiod; 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 forthe clinical study.

Study Design

Total Participants: 300
Study Start date:
December 22, 2020
Estimated Completion Date:
September 30, 2024

Study Description

In this proposal, through the integration of genome, transcriptome, protein, metabolic group, microbial group and immune cell subtype of multidimensional omics data to construct the curative effect of forecast model.The investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.Ultimate aim is to solve the depression medication selection dilemma of "trial and error", reduce medical costs, improving depression treatment experience.

Connect with a study center

  • Shanghai Mental Health Center

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.