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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT00539357
Eligibility Criteria:
Inclusion Criteria:
1. The subject is male or female outpatients age 18 to 65 years, inclusive
2. The subject meets DSM-IV criteria for Generalized Anxiety Disorder as determined by the MINI
3. Sexually active female patients of childbearing potential must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female patients of childbearing potential must have a negative pregnancy test prior to receiving study drug.
4. Written informed consent must be obtained from the subject prior to study participation.
5. The subject is in good medical health or with chronic medical conditions which are currently stable.
6. No current abuse of alcohol or other substance.
7. The subject has a total score of 20 or more on the Hamilton Anxiety Scale (HAMA) at screening.
8. The subject has a Clinical Global Impression (CGI) Severity score of 4 or more at screening.
Exclusion Criteria:
1. The subject meets DSM-IV criteria for an Axis I diagnosis (other than GAD) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by the MINI.
2. The subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal as objectively measured by the MINI and MSE.
3. The subject is clinically judged by the investigator to be at risk for homicide or is acutely homicidal as objectively measured by the MINI and MSE.
4. The subject has a psychiatric condition that would require inpatient, or partial psychiatric hospitalization.
5. Seizure disorders.
6. Significant history of medical disease (i.e. cardiovascular, hepatic (e.g. cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological, gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential or progressive neurological disorders) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
7. The subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
8. Concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
9. Current psychotherapeutic treatment except for treatment with Specific Reuptake Inhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Luvox (Fluvoxamine), and Citalopram. Potential subjects may remain on one of the SSRI medications provided that he or she has been on a stable dose for at least 4 weeks prior to entering this study; this dose remains stable throughout the remainder of this study; and it can be determined that this medication is not exacerbating the anxiety symptoms.
10. History of poor compliance or in the Investigator's judgment patients any subject whose treatment as an outpatient would be clinically contraindicated
11. The subject has attempted suicide one or more times within the past twelve months
12. The subject has a Hamilton Depression Rating Scale (HAM-D) score above 38 which suggests a moderate to severe clinical level of depressive symptoms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00539357
Study Brief:
Protocol Section:
NCT00539357