Expired Study
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Indianapolis, Indiana 46202


Purpose:

The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.


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.


NCT ID:

NCT00619892


Primary Contact:

Principal Investigator
Andrew W. Goddard, M.D.
Indiana University


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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