Clinical trial NCT00331799: Pilot Study of Duloxetine in Psychological Resilience
Official title: A Pilot Study of Duloxetine in Psychological Resilience and Its Correlation With Blockade of Serotonin and Norepinephrine Transporter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
Pharmacotherapy
Duloxetine
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2006-05-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bymaster FP, Dreshfield-Ahmad LJ, Threlkeld PG, Shaw JL, Thompson L, Nelson DL, Hemrick-Luecke SK, Wong DT. Comparative affinity of duloxetine and venlafaxine for serotonin and norepinephrine transporters in vitro and in vivo, human serotonin receptor subtypes, and other neuronal receptors. Neuropsychopharmacology. 2001 Dec;25(6):871-80. doi: 10.1016/S0893-133X(01)00298-6.
citation: Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195.
citation: Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
citation: Davidson J, Watkins L, Owens M, Krulewicz S, Connor K, Carpenter D, Krishnan R, Nemeroff C. Effects of paroxetine and venlafaxine XR on heart rate variability in depression. J Clin Psychopharmacol. 2005 Oct;25(5):480-4. doi: 10.1097/01.jcp.0000177547.28961.03.
citation: Gilmor ML, Owens MJ, Nemeroff CB. Inhibition of norepinephrine uptake in patients with major depression treated with paroxetine. Am J Psychiatry. 2002 Oct;159(10):1702-10. doi: 10.1176/appi.ajp.159.10.1702.
citation: Nemeroff CB, Schatzberg AF, Goldstein DJ, Detke MJ, Mallinckrodt C, Lu Y, Tran PV. Duloxetine for the treatment of major depressive disorder. Psychopharmacol Bull. 2002 Autumn;36(4):106-32.