NCT03230682

Brief Summary

Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can arguably predict the remission at the 12th week. Our observation study including 80 MDD patients will access resting-state function MRI to finding factors which infuencing early improvemrnt, respone and remission of antidepressants.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 24, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2018

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

July 24, 2017

Last Update Submit

July 25, 2017

Conditions

Keywords

early improvementantidepressantsmajor depression diorderresting-state fMRI

Outcome Measures

Primary Outcomes (1)

  • Early improvement

    obtain 20% decrease of HAMD-17

    the second week of treatment

Secondary Outcomes (1)

  • Response

    the 12th week of treatment

Study Arms (1)

major depressive disorder

Drug: antidepressant

Interventions

regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)

major depressive disorder

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The han nationality who living in Shanghai, Zhejiang Province and Jiangsu Province

You may qualify if:

  • right-handed; HAMD-17 more than 17; diagnosed with MDD by the Structured Clinical Interview for DSM-IV

You may not qualify if:

  • patients diagnosed with other condition in DSM-IV Axis I; pregnency; Thyroid disease; Heart Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (2)

  • Wagner S, Engel A, Engelmann J, Herzog D, Dreimuller N, Muller MB, Tadic A, Lieb K. Early improvement as a resilience signal predicting later remission to antidepressant treatment in patients with Major Depressive Disorder: Systematic review and meta-analysis. J Psychiatr Res. 2017 Nov;94:96-106. doi: 10.1016/j.jpsychires.2017.07.003. Epub 2017 Jul 4.

    PMID: 28697423BACKGROUND
  • Szegedi A, Jansen WT, van Willigenburg AP, van der Meulen E, Stassen HH, Thase ME. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J Clin Psychiatry. 2009 Mar;70(3):344-53. doi: 10.4088/jcp.07m03780. Epub 2009 Feb 24.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Shi Shenxun, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurology, Huashan Hospital

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 26, 2017

Study Start

July 25, 2017

Primary Completion

June 11, 2018

Study Completion

July 11, 2018

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations