Pilot Study of Duloxetine in Psychological Resilience

Phase 2

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	Duloxetine	Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.

Primary Outcome Measures

Name	Time	Method
Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks	baseline and 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.

Secondary Outcome Measures