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Please see Detailed Description for termination reason.
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The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with panic disorder
Due to recruitment difficulties in this adolescent population, the clinical program for alprazolam XR was cancelled and this study was terminated on 1 September 2004. There were no safety concerns that led to this decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator |
| |
| Alprazolam XR group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score | Week 6 | |
| Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly change in the PDSS-A total score | Weeks 1, 2, 3, 4, 5, and 6 | |
| Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale | Weeks 1, 2, 3, 4, 5, and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hialeah | Florida | 33013 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| alprazolam XR | Drug | Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period. |
|
|
| Weekly change and endpoint change from baseline in CGI-lmprovement scale | Weeks 1, 2, 3, 4, 5, and 6 |
| Weekly change and and endpoint change from baseline in PDSS-A item scores | Weeks 1, 2, 3, 4, 5, and 6 |
| Endpoint change from baseline in the Hamilton anxiety rating scale total score | Week 6 |
| Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score | Week 6 |
| Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire | Week 6 |
| Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit | Baseline and Week 6 |
| Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test) | Baseline and Week 6 |
| Population pharmacokinetic analysis | Weeks 2, 4, and 6 |
| Vital signs | Weeks 1, 2, 3, 4, 5, and 6 |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Pfizer Investigational Site | North Miami | Florida | 33161 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83702 | United States |
| Pfizer Investigational Site | Terre Haute | Indiana | 47802 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21208 | United States |
| Pfizer Investigational Site | Saint Paul | Minnesota | 55101 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| Pfizer Investigational Site | Lyndhurst | Ohio | 44124 | United States |
| Pfizer Investigational Site | Eugene | Oregon | 97401 | United States |
| Pfizer Investigational Site | Media | Pennsylvania | 19063 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Lake Jackson | Texas | 77566 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Wichita Falls | Texas | 76309 | United States |
| Pfizer Investigational Site | Bellevue | Washington | 98004 | United States |
| Pfizer Investigational Site | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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