Pilot Study of Duloxetine in Psychological Resilience

Duke University18 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

DuloxetineDRUG

Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and 8 weeks

Data from ClinicalTrials.gov

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