Eealy Improvement Predicts Antidepressants Response in Ad... | NCT03230682

Studies
Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

NCT03230682

Sponsor

Huashan Hospital

Status

Unknown status

Last Update Posted

Jul 26, 2017Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Major Depressive Disorder

Interventions

antidepressant

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2017Estimated

Primary Completion Date

Jun 11, 2018Estimated

Completion Date

Jul 11, 2018Estimated

First Submitted Date

Jul 24, 2017

First Submission Date that Met QC Criteria

Jul 25, 2017

First Posted Date

Jul 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2017

Last Update Posted Date

Jul 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
major depressive disorder			Drug: antidepressant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
antidepressant	Drug	regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)	major depressive disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early improvement	obtain 20% decrease of HAMD-17	the second week of treatment

Secondary Outcomes

Measure	Description	Time Frame
Response	obtain 50% decrease of HAMD-17	the 12th week of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shi Shenxun, PhD	Contact	13816203171		shishenxun@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Neurology, Huashan Hospital, Fudan University	Recruiting	Shanghai	Shanghai Municipality	200040	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28697423	Background	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.
19254516

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D011619	Psychotropic Drugs
D002491	Central Nervous System Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions