Effect of Intranasal Insulin on Depressive Symptoms in Major Depressive Disorder
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The primary aim of the study is to determine whether adjunctive intranasal insulin will exert
an antidepressant effect when compared to placebo in adults with major depressive disorder
(MDD), insufficiently responsive conventional antidepressants. There are three secondary aims
of the study (1) to determine whether adjunctive intranasal insulin will alter emotional
processing (i.e., cognitive-affective interface); (2) to determine whether early changes in
emotional processing (i.e., after a single dose at 40IU intranasal insulin) predicts
symptomatic improvement at study endpoint; and (3) to determine the effect of intranasal
insulin on neurocognitive performance (e.g., learning and memory). This initiative represents
a proof-of-concept study that insulin is important to depressive symptoms, neurocognitive
functioning, and emotional processing deficits in MDD, representing a novel and safe
therapeutic avenue.