Pilot Study of Duloxetine in Psychological Resilience

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

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

Other names: Cymbalta

Primary outcomes

Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: May 31, 2006
Registry last updated: Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed