Panic DisorderPhase 4NCT00635531
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder
A Phase 4 study testing alprazolam XR in people with Panic Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 18 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- alprazolam XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2004to Sep 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Pfizer Investigational Site
Baltimore, Maryland, 21208
Pfizer Investigational Site
Bellevue, Washington, 98004
Pfizer Investigational Site
Boise, Idaho, 83702
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Hialeah, Florida, 33013
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Lyndhurst, Ohio, 44124
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Middleton, Wisconsin, 53562
Pfizer Investigational Site
New Orleans, Louisiana
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Saint Paul, Minnesota, 55101
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Wichita Falls, Texas, 76309
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder
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
Read the 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.
- Conditions
- Panic Disorder
- Being tested
- placebo, alprazolam XR
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
alprazolam XRDrug
Also called Xanax 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Other: placebo |
| Alprazolam XR group | Active comparator | Not described Receives: Drug: alprazolam XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score
Measured: Week 6
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Measured: Week 6
Secondary outcomes (11)
Weekly change in the PDSS-A total score
Measured: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale
Measured: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and endpoint change from baseline in CGI-lmprovement scale
Measured: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and and endpoint change from baseline in PDSS-A item scores
Measured: Weeks 1, 2, 3, 4, 5, and 6
Endpoint change from baseline in the Hamilton anxiety rating scale total score
Measured: Week 6
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score
Measured: Week 6
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire
Measured: Week 6
Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit
Measured: Baseline and Week 6
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)
Measured: Baseline and Week 6
Population pharmacokinetic analysis
Measured: Weeks 2, 4, and 6
Vital signs
Measured: Weeks 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startApr 2004
- Study completionSep 2004
Why it stopped: Please see Detailed Description for termination reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635531
- Sponsor's protocol ID
- A6131002
- Status last verified
- Jan 2021
- First submitted
- 5 Mar 2008
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder
- ClinicalTrials.gov ID
- NCT00635531
- Acronym / sponsor ID
- A6131002
- Conditions
- Panic Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description for termination reason.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Sep 2004 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: placebo |
| Alprazolam XR group | Active comparator | Drug: alprazolam XR |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboPlacebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam | Other | Placebo group |
| alprazolam XRAlso: Xanax XROral 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. | Drug | Alprazolam XR group |
Primary outcome
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score
Time frame: Week 6
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Time frame: Week 6
11 secondary outcomes
Weekly change in the PDSS-A total score
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and endpoint change from baseline in CGI-lmprovement scale
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and and endpoint change from baseline in PDSS-A item scores
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Endpoint change from baseline in the Hamilton anxiety rating scale total score
Time frame: Week 6
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score
Time frame: Week 6
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire
Time frame: Week 6
Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit
Time frame: Baseline and Week 6
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)
Time frame: Baseline and Week 6
Population pharmacokinetic analysis
Time frame: Weeks 2, 4, and 6
Vital signs
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Results and safety
The study was stopped early (reason given: Please see Detailed Description for termination reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alprazolam XR in people with Panic Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Please see Detailed Description for termination reason.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.