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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208932
• Other study ID #: ZH2018ZDA29
• Status: Recruiting
• Start date: August 12, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2019
• Source: Shanghai Mental Health Center
• Contact: Daihui Peng, MD.PhD.
• Phone: 18017311136
• Email: pdhsh[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SSRIs
Selective Serotonin Reuptake Inhibitors

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission of acute phase	scored 7 or lower on the Hamilton's Depression Scale with 24 items	12th week