Panic Disorder
Conditions
Brief summary
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
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
Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
DRUGalprazolam XR
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.
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 DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents * At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening * At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline * At least one 4-symptom panic attack in the 7 days prior to baseline
Exclusion criteria
* Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence * Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder * Any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder * A CDRS-R score \>35
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Weekly change in the PDSS-A total score | Weeks 1, 2, 3, 4, 5, and 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 |
| Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire | Week 6 |
| Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale | Weeks 1, 2, 3, 4, 5, and 6 |
Countries
United States
Outcome results
None listed