NCT02023567

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

December 15, 2013

Last Update Submit

May 18, 2016

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The changes of HAMA total score at 8 weeks from baseline

    week 0,2,4,8

  • The change of CGI score at 8 weeks from baseline

    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

Study Arms (2)

MDD group

EXPERIMENTAL

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

Healthy controls

NO INTERVENTION

This group just receive baseline evaluation and did not receive any intervention.

Interventions

SSRIsDRUG

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

Also known as: selective serotonin reuptake inhibitors
MDD group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Beijing Anding Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

ACTIVE NOT RECRUITING

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

RECRUITING

Hebei Medical University First Hospital

Shijiazhuang, Hebei, China

ACTIVE NOT RECRUITING

Dalian Seventh People's Hospital

Dalian, Liaoning, China

ACTIVE NOT RECRUITING

First Hospital of China Medical University

Shenyang, Liaoning, China

ACTIVE NOT RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

ACTIVE NOT RECRUITING

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

ACTIVE NOT RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

ACTIVE NOT RECRUITING

Related Publications (7)

  • Cui F, Liu Q, Lv X, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Effect of childhood trauma on cognitive function in individuals with major depressive disorder and healthy controls. J Affect Disord. 2025 Feb 15;371:196-204. doi: 10.1016/j.jad.2024.10.059. Epub 2024 Oct 19.

    PMID: 39433132DERIVED

  • Lin J, Li JT, Kong L, Liu Q, Lv X, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yu X, Si T, Su YA. Proinflammatory phenotype in major depressive disorder with adulthood adversity: In line with social signal transduction theory of depression. J Affect Disord. 2023 Nov 15;341:275-282. doi: 10.1016/j.jad.2023.08.104. Epub 2023 Aug 30.

    PMID: 37657624DERIVED

  • 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.

    PMID: 34985583DERIVED

  • 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.

    PMID: 33874911DERIVED

  • 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.

    PMID: 31959583DERIVED

  • 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.

    PMID: 29664050DERIVED

  • 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.

    PMID: 27422150DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Study Officials

  • Xin Yu, MD

    Peking University Sixth Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianmei Si, MD

CONTACT

86-10-62723748si.tian-mei@163.com

Gang Wang, MD

CONTACT

gangwangdoc@mail1.bbuser.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2013

First Posted

December 30, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

CN(9)