PMID- 17311303
OWN - NLM
STAT- MEDLINE
DCOM- 20080625
LR  - 20220317
IS  - 1091-4269 (Print)
IS  - 1091-4269 (Linking)
VI  - 25
IP  - 3
DP  - 2008
TI  - Efficacy and safety of duloxetine in the treatment of generalized anxiety 
      disorder: a flexible-dose, progressive-titration, placebo-controlled trial.
PG  - 182-9
AB  - Generalized anxiety disorder (GAD), a prevalent and chronic illness, is 
      associated with dysregulation in both serotonergic and noradrenergic 
      neurotransmission. Our study examined the efficacy, safety, and tolerability of 
      duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and 
      norepinephrine, for short-term treatment of adults with GAD. In a 10-week, 
      double-blind, progressive-titration, flexible-dose trial, 327 adult outpatients 
      with a DSM-IV-defined GAD diagnosis were randomized to duloxetine 60-120 mg (DLX, 
      N=168) or placebo (PLA, N=159) treatment. The primary efficacy measure was mean 
      change from baseline to endpoint in Hamilton Anxiety Scale (HAMA) total score. 
      Secondary outcome measures included response rate (HAMA total score reduction > 
      or =50% from baseline), Clinician Global Impression-Improvement (CGI-I) scores, 
      and Sheehan Disability Scale (SDS) scores. Patients who received duloxetine 
      treatment demonstrated significantly greater improvement in HAMA total scores 
      (P=.02); a higher response rate (P=.03), and greater improvement (P=.04) than 
      patients who received placebo. Duloxetine-treated patients were also 
      significantly more improved than placebo-treated patients on SDS global 
      functional (P<.01) and work, social, and family/home impairment scores (P<.05). 
      The rate of discontinuation due to adverse events (AEs) was higher for the 
      duloxetine group compared with the placebo group (P=.002). The AEs most 
      frequently associated with duloxetine were nausea, dizziness, and somnolence. 
      Duloxetine was an efficacious, safe, and well-tolerated treatment that resulted 
      in clinically significant improvements in symptom severity and functioning for 
      patients with GAD.
FAU - Rynn, Moira
AU  - Rynn M
AD  - University of Pennsylvania, Philadelphia, Pennsylvania, USA.
FAU - Russell, James
AU  - Russell J
FAU - Erickson, Janelle
AU  - Erickson J
FAU - Detke, Michael J
AU  - Detke MJ
FAU - Ball, Susan
AU  - Ball S
FAU - Dinkel, Jeff
AU  - Dinkel J
FAU - Rickels, Karl
AU  - Rickels K
FAU - Raskin, Joel
AU  - Raskin J
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Depress Anxiety
JT  - Depression and anxiety
JID - 9708816
RN  - 0 (Antidepressive Agents)
RN  - 0 (Placebos)
RN  - 0 (Thiophenes)
RN  - 9044SC542W (Duloxetine Hydrochloride)
SB  - IM
MH  - Adult
MH  - Ambulatory Care
MH  - Antidepressive Agents/adverse effects/*therapeutic use
MH  - Anxiety Disorders/diagnosis/*drug therapy/psychology
MH  - Dizziness/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Duloxetine Hydrochloride
MH  - Female
MH  - Humans
MH  - Male
MH  - Nausea/chemically induced
MH  - Placebos
MH  - Psychiatric Status Rating Scales/statistics & numerical data
MH  - Severity of Illness Index
MH  - Sleep Wake Disorders/chemically induced
MH  - Thiophenes/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2007/02/22 09:00
MHDA- 2008/06/26 09:00
CRDT- 2007/02/22 09:00
PHST- 2007/02/22 09:00 [pubmed]
PHST- 2008/06/26 09:00 [medline]
PHST- 2007/02/22 09:00 [entrez]
AID - 10.1002/da.20271 [doi]
PST - ppublish
SO  - Depress Anxiety. 2008;25(3):182-9. doi: 10.1002/da.20271.