Pilot Study of Duloxetine in Psychological Resilience

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore benefits of duloxetine in enhancing psychological resilience and to understand the relevance of inhibiting of both serotonin (5HT) and norepinephrine (NE)to therapeutic responses.

Detailed Description
-----------------
This is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive Disorder (MDD).

Official Title
-----------------
A Pilot Study of Duloxetine in Psychological Resilience and Its Correlation With Blockade of Serotonin and Norepinephrine Transporter

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-65 primary diagnosis of MDD based on Diagnostic Standard Manual(DSM-IV) criteria and assessed by the MINI International Neuropsychiatric Interview Montgomery-Asberg Depression Rating Scale (MADRS)score of at least 20 on baseline Minimum Clinical Global Impressions of Severity (CGS) severity score of 4 Ability to provide written consent form A negative serum pregnancy test for women of childbearing potential Exclusion Criteria: Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition History of substance abuse or dependence within the last 6 months Suicide risk or serious suicide attempt within the last year Clinically significant medical condition or laboratory abnormality Women of childbearing potential who are unwilling to practice an acceptable method of contraception Subjects needing concurrent use of psychotropic medications History of sensitivity to duloxetine History of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks) Subjects taking monoamine oxidase inhibitors (MAOIs) Subjects with uncontrolled narrow-angle glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg. | Drug: Duloxetine<br>* Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.<br>* Other names: Cymbalta;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks | CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience. | baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Pharmacotherapy, Duloxetine