Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

Major Depressive Disorder Clinical Trial

Official title:

Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230682
• Other study ID #: KY2017-01
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2017
• Last updated: July 25, 2017
• Start date: July 25, 2017
• Est. completion date: July 11, 2018

Study information

• Verified date: July 2017
• Source: Huashan Hospital
• Contact: Shi Shenxun, PhD
• Phone: 13816203171
• Email: shishenxun[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 11, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• antidepressant
regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)

Locations

Country	Name	City	State
China	Dept. of Neurology, Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 Psych — View Citation

Wagner S, Engel A, Engelmann J, Herzog D, Dreimüller N, Müller 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 Jul 4;94:96-106. doi: 10.1016/j.jpsychires.2017.07.003. [Epub ahead of print] Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early improvement	obtain 20% decrease of HAMD-17	the second week of treatment
Secondary	Response	obtain 50% decrease of HAMD-17	the 12th week of treatment