- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061877
Anxiety Depression and Rheumatoid Arthritis (ADAR)
September 18, 2018 updated by: Kun Zou, Sichuan Provincial People's Hospital
The Effect of Anxiety and Depression on Treatment Response in Rheumatoid Arthritis
Anxiety and depression are highly prevalent in people with rheumatoid arthritis (RA).This study is to investigate the effect of anxiety and depression on treatment response in people with RA using observational longitudinal study design.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
134
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
People diagnosed with rheumatoid arthritis according to American College Rheumatology (ACR) criteria 2010
Description
Inclusion Criteria:
- People diagnosed with rheumatoid arthritis according to the American College Rheumatology (ACR) criteria 2010
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Anxiety or depression
|
The presence of anxiety or depression measured by the Hospital Anxiety and Depression Scale (HAD)
|
|
Non-anxiety or depression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical remission
Time Frame: 6 months
|
Clinical remission defined by the Disease Activity Score 28 (DAS28) with a score less than 2.6
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kun Zou, PhD, Sichuan Provincial People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2019
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
February 20, 2017
First Submitted That Met QC Criteria
February 20, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
September 19, 2018
Last Update Submitted That Met QC Criteria
September 18, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SichuanPPH201701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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