Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

• Sponsor: Huashan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03230682
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: antidepressant

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder
• Anticipated Study Start Date: Jul 25, 2017
• Anticipated Primary Completion Date: Jun 11, 2018
• Anticipated Study Completion Date: Jul 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
major depressive disorder	Drug: antidepressant; regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)

Outcome Measures

Primary Outcome Measures

1. Early improvement [the second week of treatment]

   obtain 20% decrease of HAMD-17

Secondary Outcome Measures

1. Response [the 12th week of treatment]

   obtain 50% decrease of HAMD-17

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Neurology, Huashan Hospital, Fudan University	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Wagner S, Engel A, Engelmann J, Herzog D, Dreimüller N, Müller MB, Tadić 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. Review.

• Responsible Party: Jianhui Fu, Department of Neurology, Huashan Hospital, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT03230682
• Other Study ID Numbers: KY2017-01
• First Posted: Jul 26, 2017
• Last Update Posted: Jul 26, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianhui Fu, Department of Neurology, Huashan Hospital, Huashan Hospital: early improvement; antidepressants; major depression diorder; resting-state fMRI
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Antidepressive Agents

Study Results

No Results Posted as of Jul 26, 2017