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| Descriptive Information Fields | |||||||||||||
| Brief Title † | A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients | ||||||||||||
| Official Title † | A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients | ||||||||||||
| Brief Summary | The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program. |
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| Detailed Description | |||||||||||||
| Study Phase | Phase IV | ||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||
| Primary Outcome Measure † | Panic symptoms scale score CGI-I CGI-S |
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| Secondary Outcome Measure † | Sheehan Disability Scale | ||||||||||||
| Condition † | Panic Disorder | ||||||||||||
| Intervention † | Drug: Sertraline and Alprazolam XR | ||||||||||||
| MEDLINE PMIDs | |||||||||||||
| Links | |||||||||||||
| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Completed | ||||||||||||
| Enrollment † | 150 | ||||||||||||
| Start Date † | December 2003 | ||||||||||||
| Completion Date | September 2007 | ||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts †† | |||||||||||||
| Location Countries † | United States | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00198094 | ||||||||||||
| Organization ID | 0311-34 | ||||||||||||
| Secondary IDs †† | IU 1003 | ||||||||||||
| Study Sponsor † | Indiana University School of Medicine | ||||||||||||
| Collaborators †† | Pfizer University of Pennsylvania University of South Florida |
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| Investigators † |
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| Information Provided By | Indiana University | ||||||||||||
| Verification Date | October 2007 | ||||||||||||
| First Received Date † | September 12, 2005 | ||||||||||||
| Last Updated Date | October 19, 2007 | ||||||||||||