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

NCT04208932 | Unknown

• 1 other identifier: ZH2018ZDA29
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• remission of acute phase

  scored 7 or lower on the Hamilton's Depression Scale with 24 items

  12th week

Study Arms (2)

MDD

major depressive disorder

Drug: SSRIs

HC

healthy control

Interventions

SSRIs DRUG

Selective Serotonin Reuptake Inhibitors

MDD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• years old;
• Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
• Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
• With enough audio-visual ability and comprehensive ability to accomplish the visits;
• Be necessary and suitable to accept the treatment of antidepressants;
• Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Daihui Peng, MD.PhD.

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Daihui Peng, MD.PhD.

CONTACT

18017311136; pdhsh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 23, 2019
• Study Start: August 12, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

CN (1)