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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00074802
Eligibility Criteria:
Inclusion Criteria:
* Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for generalized social phobia
* Willing and able to give written informed consent
* English-speaking
Exclusion Criteria:
* Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders
* Suicidal thoughts
* History of failed paroxetine treatment of at least 6 weeks' duration at adequate doses or a history of failed outcome of a previous adequate trial of CBT
* Clinically significant and/or unstable medical disease
* Pregnancy or breast-feeding. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study through the use of an effective method of contraception.
* Alcohol or substance abuse or dependence within the past 3 months. Patients with a positive drug screen but no substance abuse disorder will be eligible for the study, provided they have not met criteria for abuse/dependence within the last 6 months and provide two clean urine samples 2 weeks apart.
* Current or past history of seizure disorder (except febrile seizure in childhood)
* Conditions that contraindicate the use of paroxetine
* Inability to tolerate or unwillingness to accept a drug-free period of 4 weeks for monoamine oxidase inhibitors (MAOIs) or fluoxetine and 2 weeks for other selective serotonin reuptake inhibitors (SSRIs), neuroleptics, antidepressants, benzodiazepines, mood stabilizers, buspirone, beta-adrenergic blockers, or other psychotropic drugs prior to beginning the study
* Currently receiving psychotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00074802
Study Brief:
Protocol Section:
NCT00074802