Panic Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in adolescents with panic disorder.
Detailed description
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.
Interventions
OTHERplacebo
Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
DRUGalprazolam XR
Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* A primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of panic disorder with or without agoraphobia based on the Mini-International Neuropsychiatric Interview for Children and Adolescents * Subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline * To enter Study A6131007, subjects must have completed Study A6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment.
Exclusion criteria
* Subjects must continue to meet all of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam | Week 24 (taper baseline), Weeks 25-29, and end of taper visit |
| The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR | Weeks 6, 8, 12, 16, 20, and 24 |
| Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Endpoint change compared with baseline in CGI-Severity score | Weeks 12 and 24 |
| Endpoint change from baseline in Hamilton Anxiety Rating scale | Weeks 12 and 24 |
| Descriptive estimates of the persistence of safety events and adverse events | Week 24 |
| Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score | Weeks 12 and 24 |
| Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores | Weeks 12 an 24 |
| Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale | Weeks 12 and 24 |
Countries
United States
Outcome results
None listed