The Investigation of the Depression in Osteoarthritis | NCT02924662

Studies
The Investigation of the Depression in Osteoarthritis

NCT02924662

Sponsor

Dalian Municipal Central Hospital

Status

Unknown status

Last Update Posted

Oct 5, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Depression

Interventions

There is no intervention.

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Not provided

First Submitted Date

Oct 4, 2016

First Submission Date that Met QC Criteria

Oct 4, 2016

First Posted Date

Oct 5, 2016Estimated

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

Oct 4, 2016

Last Update Posted Date

Oct 5, 2016Estimated

Description Module

Brief Summary

Studies have reported that the patient's psychological state such as anxiety, depression and other emotion affect the therapeutic effect of osteoarthritis, also may be the important reason for the poor knee joint osteoarthritis efficacy.

The aim of this study are firstly to investigate the depression status of patients with osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression will affect depression status, ultimately, provide reference for clinical.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Kellgren and Lawrence classification I	Grade I Kellgren and Lawrence radiographic changes.	Other: There is no intervention.
Kellgren and Lawrence classification II	Grade II Kellgren and Lawrence radiographic changes.
Kellgren and Lawrence classification III	Grade III Kellgren and Lawrence radiographic changes.
Kellgren and Lawrence classification IV	Grade IV Kellgren and Lawrence radiographic changes.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention.	Other		Kellgren and Lawrence classification I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Western Ontario and McMaster OA index (WOMAC)		Day 1
American knee society knee score		Day 1
Hamilton Depression Scale-17（HAMD-17）		Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis and the 2010 Chinese Medical Association clinical criteria for knee osteoarthritis.

Exclusion Criteria:

Patients with rheumatoid arthritis patients with a history of depression before osteoarthritis pathogenesis patients who can't cooperate with related inspection and assessment Patients with mental illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study group will be taken from a single centre. The patient population will be patients who are diagnosed with osteoarthritis. Participants will have a comprehensive and detailed assessment by a qualified doctor. After the assessment，the participants who are diagnosed with osteoarthritis and conformed to fit the eligibility criteria will be invited to join the investigation.

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	Nov 9, 2016
Reset	Jan 5, 2017
Release	Jan 15, 2017
Reset	Mar 3, 2017
Release	Mar 28, 2017
Reset	Jun 15, 2017
Release	Dec 20, 2017
Reset	Oct 18, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 9, 2016			Jan 5, 2017
Jan 15, 2017

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior