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A Kynurenine Pathway-based Molecular Imaging Study of Individualized Diagnosis and Treatment for Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208932
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
Major depressive disorder (MDD) is a chronic disease with high incidence rate, high recurrent rate and need whole course medical management. Varied clinical symptoms and unclear pathogenesis cause a series of clinical problem, such as low diagnostic rate and low effective treatment rate. Based on neuroimmune mechanisms of MDD, our previous study indicates that kynurenine pathway (KP) in serum may be the connections between central immune and peripheral immune, that key factors of KP may change the brain structure and function through affecting the central immune. The core research issue of this project are the inherent associations between metabonomics of inflammatory factors in KP, clinical phenotypes of MDD, and neuroimaging features. This project will focus on first-episode MDD, mass spectrometry analysis of KP factors will be conducted first, also multi-modal neuroimaging techniques will be applied to detect topological characteristics of brain structure and function in MDD and extract standard models, then correlation analyses will be performed between these molecular biological features and multi-dimensional clinical data in order to integrate KP metabonomics, core clinical characteristics (depressed mood, energy loss, interest loss and so on), neuroimaging biomarkers, and finally construct the deep learning based standard diagnostic technique of MDD. Additionally, this project will follow up MDD patients with different core clinical characteristics to certificate the aforementioned diagnostic technique as well as explore optimized treatment for different clinical subtypes.

Condition or disease Intervention/treatment
Major Depressive Disorder Drug: SSRIs

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Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Kynurenine Pathway-based Molecular Imaging Study of Individualized Diagnosis and Treatment for Major Depressive Disorder
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MDD
major depressive disorder
Drug: SSRIs
Selective Serotonin Reuptake Inhibitors

HC
healthy control



Primary Outcome Measures :
  1. remission of acute phase [ Time Frame: 12th week ]
    scored 7 or lower on the Hamilton's Depression Scale with 24 items


Biospecimen Retention:   Samples With DNA
blood sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
370 patients with the major depressive disorder who are first-episode drug-naive or medication-free for no less than 2 weeks; 70 healthy participants
Criteria

Inclusion Criteria:

  1. 18-60 years old;
  2. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
  3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
  4. With enough audio-visual ability and comprehensive ability to accomplish the visits;
  5. Be necessary and suitable to accept the treatment of antidepressants;
  6. Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
  7. With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.

Exclusion Criteria:

  1. Severe medical or neurological problems;
  2. Previous mania or hypomania episodes;
  3. Female patients who are pregnant, planning to be pregnant or breastfeeding;
  4. Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
  5. Had electroconvulsive therapy, modified electroconvulsive therapy or repetitive transcranial magnetic stimulation in the past 6 months;
  6. Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208932


Contacts
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Contact: Daihui Peng, MD.PhD. 18017311136 pdhsh@126.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Daihui Peng, M.D.,Ph.D.    18017311136    pdhsh@126.com   
Sponsors and Collaborators
Shanghai Mental Health Center
Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Daihui Peng, MD.PhD. Shanghai Mental Health Center
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04208932    
Other Study ID Numbers: ZH2018ZDA29
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms