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Phase 3 N=210 Randomized Quadruple-blind Treatment

Duloxetine for the Treatment of Generalized Anxiety Disorder

Generalized Anxiety Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00803361 ↗
Enrolled (actual)
210
Serious AEs
0.5%
Results posted
Dec 2010
Primary outcome: Primary: Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint — 12.76; 13.56; -6.38; -5.29 Units on a scale — p=0.006

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Duloxetine (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint		 12.76; 13.56; -6.38; -5.29 0.006 sig
SECONDARY
Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint		 24.50; 24.24; -14.42; -11.62 0.024 sig
SECONDARY
Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint		 2.08; 2.54 0.004 sig
SECONDARY
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint		 3.39; 4.22; -1.78; -1.88; 1.17; 1.51 0.125
SECONDARY
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores		 5.94; 5.85; -3.27; -2.59; 5.84; 5.73 0.076
SECONDARY
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint		 27.56; 31.94; -15.28; -13.40; 21.11; 24.52 0.063
SECONDARY
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint		 6.90; 6.62; -2.95; -1.96 0.068

Summary

This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder

Eligibility Criteria

Inclusion Criteria

  • Psychiatric Diagnosis of generalized anxiety disorder (GAD)
  • Outpatients
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD
  • Clinical Global Impression (CGI) of Severity Score of at least moderate
  • Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12

Exclusion Criteria

  • Pregnancy or breast feeding
  • Serious medical illness
  • Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months
  • panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year
  • lifetime history of bipolar or psychosis
  • Any unstable serious medical condition for which duloxetine would not be allowed
  • Any use of medications that are not allowed
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00803361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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