- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230682
Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder
July 25, 2017 updated by: Jianhui Fu, Huashan Hospital
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shi Shenxun, PhD
- Phone Number: 13816203171
- Email: shishenxun@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Recruiting
- Dept. of Neurology, Huashan Hospital, Fudan University
-
Contact:
- Jie Tang
- Phone Number: +8618818210880
- Email: tan11711@hotmail.com
-
-
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
14 years to 53 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The han nationality who living in Shanghai, Zhejiang Province and Jiangsu Province
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
major depressive disorder
|
regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early improvement
Time Frame: the second week of treatment
|
obtain 20% decrease of HAMD-17
|
the second week of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response
Time Frame: the 12th week of treatment
|
obtain 50% decrease of HAMD-17
|
the 12th week of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
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)
July 25, 2017
Primary Completion (Anticipated)
June 11, 2018
Study Completion (Anticipated)
July 11, 2018
Study Registration Dates
First Submitted
July 24, 2017
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 26, 2017
Study Record Updates
Last Update Posted (Actual)
July 26, 2017
Last Update Submitted That Met QC Criteria
July 25, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2017-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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