Augmentation of Zonisamide in Poor or Non-responder Patients Treated with Duloxetine for Single or Recurrent Unipolar Major Depressive Episode

Abstract

Objectives:

The aim of our ongoing study is to investigate the effectiveness of Zonisamide augmentation to Duloxetine in partial and non-responder patients in course of Unipolar Major Depressive Episode.

Method:

35 outpatients will be enrolled in a 12-weeks open-label study including both genders, 18 to 65 years old subjects. Unipolar Major Depressive Episode diagnosis will be performed at screening time using “Structured Clinical Interview for DSM-IV-Axis-I Disorders- Italian 1996 version” (SCID-I, First et al., 1996) and by a ≥14 total score for the “Quick Inventory of Depressive Symptomathology-Self Rated” (QIDS-SR, Rush et al., 2003). Patients will be repeatedly evaluated during the course of the study using a wide range of mood and anxiety rating scales and monitoring biomarkers such as electroretinogram b-wave amplitude, interleukins, flogosis and BDNF factors etc. At week 6, Duloxetine partial/non responders will be augmetated to Zonisamide and further evaluations of mentioned markers will be repeated. A “Fisher-test” or χ² analysis will be performed at the end of the study. Expected p will be ≤ 0,005.

Hypothesis:

We expect Zonisamide augmentation to be an effective treatment for SNRI-resistant Major Depression.