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:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT01629966
Eligibility Criteria:
Inclusion Criteria:
* Male and female, 18 - 70 years of age
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)
* Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)
Exclusion Criteria:
* Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control
* History of meeting DSM-IV-TR criteria for any of the following:
* Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
* Any depressive episode with psychotic or catatonic features
* Panic disorder with or without agoraphobia
* Obsessive-compulsive disorder
* Schizophrenia, schizoaffective, or other psychotic disorder
* Bulimia or anorexia nervosa
* Presence of borderline personality disorder or antisocial personality disorder
* Mental retardation, dementia, amnesia, or other significant cognitive disorders
* Patients who are considered a suicide risk
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01629966
Study Brief:
Protocol Section:
NCT01629966