Phase 3 N=511 Randomized Double-blind Treatment

Experimental Medication For the Treatment of Generalized Anxiety Disorder

Anxiety Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00097708 ↗

Enrolled (actual)

511

Serious AEs

1.4%

Results posted

Oct 2014

Primary outcome: Primary: Change in HAM-A Total Score — -12.9; -15.7; -12.5 Units on a Scale — p=0.6540

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: experimental anti-anxiety drug (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jazz Pharmaceuticals
Primary completion: —

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in HAM-A Total Score	-12.9; -15.7; -12.5	0.6540

Summary

The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Eligibility Criteria

Inclusion Criteria

Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.

Exclusion Criteria

No other primary psychiatric diagnosis besides GAD.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00097708). 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.