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 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT00619892
Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent
* Diagnosis of Panic Disorder by DSM-IV TR and confirmed by MINI plus interview
* Females and males ages 18-65 years old
* Female patients of childbearing potential must by using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
* Able to understand and comply with the requirements of the study
* Have a CGI illness severity score = or \> 4
* Patients with comorbid major depression, dysthymia or other anxiety problems are eligible to participate as well.
Exclusion criteria:
* Pregnancy or lactation
* Any DSM-IV TR Axis I disorder not mentioned in the inclusion requirements
* Suicidal or danger to self or others
* Known intolerance to quetiapine fumarate or intolerance to SSRI therapy
* Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to : ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
* Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to : phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
* Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV TR criteria within 4 weeks prior to enrollment
* Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
* Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension) as judged by the investigator
* Involvement in the planning and conduct of the study
* Previous enrollment or randomization of treatment in the present study
* Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
* A patient with a diagnosis of Type I or Type II Diabetes Mellitus (DM)
* An absolute neutrophil count (ANC) of 1.5 x 109 per liter
* A lifetime history of a pre-existing CNS/neurological disorder e.g. epilepsy, TBI, brain tumor
* Patient with severe personality disorders
* Patients who have started a new course of psychotherapy (CBT, supportive, insight-oriented) within 1 month of the screening visit
* Patients unwilling to refrain from participation in psychotherapy during the 9-week period of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00619892
Study Brief:
Protocol Section:
NCT00619892