A Study of the Neurobiology of Depression

Phase 4 Completed 60 enrolled Eli Lilly and Company

Non-randomizedParallel-groupOpen-labelBasic science

Summary

Previous research studies have shown that depression is associated with changes in structure and activity in different parts of the brain and that antidepressant medication can affect brain activity in different parts of the brain in individuals suffering from depression. The primary purpose of the study is to find out more about how the antidepressant medication duloxetine affects brain activity and structure in individuals with depression.

Timeline

Start: 2010-01
Primary completion: 2013-03
Completion: 2013-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Duloxetine vs Healthy Participants; p = 0.457; Mixed Models Analysis; note: the significance level was 0.05 for a 2-sided test. NCT01051466 ↗

Publications

Fu CH, Costafreda SG, Sankar A, Adams TM, Rasenick MM, Liu P, Donati R, Maglanoc LA, Horton P, Marangell LB. Multimodal functional and structural neuroimaging investigation of major depressive disorder following treatment with duloxetine. BMC Psychiatry. 2015 Apr 14;15:82. doi: 10.1186/s12888-015-0457-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	60 mg	Oral
Subject	Duloxetine	Small molecule	120 mg	Oral