Objective Diagnostic Markers and Personalized Intervention in MDD Patients

The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)

Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It's assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of MDD for classifying MDD into "genetic type", "environmental type" and "others" based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD patients.

Study Overview

• Status: Unknown
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: SSRIs

• Study Type: Interventional
• Enrollment (Anticipated): 2400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Sixth Hospital
      • Contact: Qi Liu; Phone Number: 86-13671013073 86-10-82801955; Email: liu_qee@sina.com
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Anding Hospital
      • Contact: Gang Wang; Phone Number: 86-13911695727; Email: gangwangdoc@gmail.com
      • Contact: Changqing Hu; Phone Number: 86-13661106500; Email: coannhu@126.com
    • Beijing, Beijing, China
      • Active, not recruiting
      • Peking Union Medical College Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Active, not recruiting
      • Hebei Medical University First Hospital
  • Liaoning
    • Dalian, Liaoning, China
      • Active, not recruiting
      • Dalian Seventh People's Hospital
    • Shenyang, Liaoning, China
      • Active, not recruiting
      • First Hospital of China Medical University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Active, not recruiting
      • First Hospital of Shanxi Medical University
  • Tianjin
    • Tianjin, Tianjin, China
      • Active, not recruiting
      • Tianjin Anding Hospital
    • Tianjin, Tianjin, China
      • Active, not recruiting
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

1. For MDD group:

   Inclusion criteria:

   • Age between 18-55, male or female;
   • The diagnosis of MDD consistent with DSM-IV (M.I.N.I)
   • First-episode or relapsed;
   • Certain ability of reading and writing to complete the questionnaire survey and psychological assessment.
   • All participants provide written confirmation of informed consent prior to engaging the study protocol.

   Exclusion criteria:

   • Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment;
   • Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
   • Not signed the informed consent;
   • Been engaging other studies.
2. For Healthy control group

Inclusion criteria:

• age between 18 and 55 years at the time of enrollment;
• providing written confirmation of informed consent prior to engaging the study.

Exclusion criteria:

• lifetime or current diagnosis of any mental diseases;
• severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
• not signed the informed consent;
• been engaging other studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDD group; Drugs: SSRIs fluoxertine hydrochloride (20- 60m/day),paroxetine hydrochloride (20- 60m/day),sertraline hydrochloride (50- 200m/day),citalopram (20-60m/day), escitalopram (10-20mg/day),fluvoxamine (50-300mg/day)	Drug: SSRIs; fluoxertine hydrochloride 20-60mg/day, paroxetine hydrochloride 20-60mg/day, sertraline hydrochloride 50-200mg/day, citalopram 20-60mg/day, escitalopram 10-20mg/day, fluvoxamine 50-300mg/day; Other Names: selective serotonin reuptake inhibitors
No Intervention: Healthy controls; This group just receive baseline evaluation and did not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of HAMD total score at 8 weeks from baseline	The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group	week 0,2,4,8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of HAMA total score at 8 weeks from baseline	The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group	week 0,2,4,8
The change of CGI score at 8 weeks from baseline	The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group	week 0,2,4,8
The prognosis after the intervention		Up to 2 years
Number of participants with serious and non-serious adverse events		Up to two years

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Peking Union Medical College Hospital; Tianjin Medical University General Hospital; First Hospital of China Medical University; Capital Medical University; The First Affiliated Hospital of Shanxi Medical University; The First Hospital of Hebei Medical University; Tianjin Anding Hospital; Dalian Seventh People's Hospital
• Investigators: Principal Investigator: Xin Yu, MD, Peking University Sixth Hospital

Publications and helpful links

General Publications

• Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yan H, Wang Y, Yu X, Si T. Childhood adversity, adulthood adversity and suicidal ideation in Chinese patients with major depressive disorder: in line with stress sensitization. Eur Arch Psychiatry Clin Neurosci. 2022 Aug;272(5):887-896. doi: 10.1007/s00406-021-01375-4. Epub 2022 Jan 5.
• Cui F, Liu Q, Lv X, Leonhart R, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Severe sleep disturbance is associated with executive function impairment in patients with first-episode, treatment-naive major depressive disorders. BMC Psychiatry. 2021 Apr 19;21(1):198. doi: 10.1186/s12888-021-03194-2.
• Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Wang Y, Yu X, Si T. Perceived stressfulness mediates the effects of subjective social support and negative coping style on suicide risk in Chinese patients with major depressive disorder. J Affect Disord. 2020 Mar 15;265:32-38. doi: 10.1016/j.jad.2020.01.026. Epub 2020 Jan 10.
• Lin JY, Huang Y, Su YA, Yu X, Lyu XZ, Liu Q, Si TM. Association between Perceived Stressfulness of Stressful Life Events and the Suicidal Risk in Chinese Patients with Major Depressive Disorder. Chin Med J (Engl). 2018 Apr 20;131(8):912-919. doi: 10.4103/0366-6999.229898.
• Lv X, Si T, Wang G, Wang H, Liu Q, Hu C, Wang J, Su Y, Huang Y, Jiang H, Yu X. The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol. BMC Psychiatry. 2016 Jul 15;16:240. doi: 10.1186/s12888-016-0953-z.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 15, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin Receptor Agonists; Serotonin; Serotonin Uptake Inhibitors
• Other Study ID Numbers: 2013CB531305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After enrollment completion,we will decided whether share data or not.