Generalized Anxiety Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).
Interventions
DRUGGabitril
Sponsors
Cephalon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
• Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).
Exclusion criteria
* Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD * Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months * Have been diagnosed with any eating disorder within the past six months * Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder * Have any history of alcohol or substance abuse within 3 months of screening * Have any history of seizures, including febrile seizures * Have any history of head trauma associated with loss of consciousness within the past 15 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD | — |
Countries
United States
Outcome results
None listed