Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT00788034
Eligibility Criteria:
Inclusion Criteria:
The patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02).
* The patient has a HAM-A total score \>=20 at screening and baseline visits
* The patient has a HAM-A score \>=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits
* The patient has a MADRS total score \<=16 at screening and baseline visits
Exclusion Criteria:
* Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI)
* Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
* Women of childbearing potential not using effective contraception
Other protocol-defined inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00788034
Study Brief:
Protocol Section:
NCT00788034