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| ID | Type | Description | Link |
|---|---|---|---|
| IU 1003 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| University of Pennsylvania | OTHER |
| University of South Florida | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline and Alprazolam XR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Panic symptoms scale score | ||
| CGI-I | ||
| CGI-S |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan Disability Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew W Goddard, M.D. | Indiana University | Principal Investigator |
| Karl Rickles, M.D. | University of Pennsylvania | Principal Investigator |
| David Sheehan, M.D., M.B.A. | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida, Department of Psychiatry and Behavioral Medicine | Tampa | Florida | 33613 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | A randomized double-blind comparison of sertraline with early alprazolam XR Co-administration vs. sertraline/placebo for panic disorder. Goddard AW, Ball SG, Hastings AK, Shekhar A, Rickels K, Rynn M, Janavs J, Sheehan DV. BIOLOGICAL PSYCHIATRY 57 (8): 62S-62S 220 Suppl. S, APR 15 2005. IDS Number: 915VE ISSN: 0006-3223 |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| University Hospital Outpatient Center, Psychiatry |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University of Pennsylvania, Mood and Anxiety Disorders Section | Philadelphia | Pennsylvania | 19104-3309 | United States |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |