Panic DisorderPhase 4NCT00634790
A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
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 47 sites in United States.
Trial summary
The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. 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?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 47 sitesUnited States
- Study dates
- May 2004to Oct 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
- Subjects must meet one of the following 6 diagnoses: a. A current diagnosis of panic disorder with or without agoraphobia; b. Generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. Social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. Separation anxiety with a history of at least one panic attack in the course of their illness; e. Posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. Anxiety not otherwise specified with a history of at least one panic attack in the course of their illness.
- Educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with.
Who cannot join
- Current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence.
- Current (in the past 3 months) diagnosis of alcohol and/or substance abuse.
- Primary diagnosis of 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 eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder.
- A Childhood Depression Rating Scale, Revised score >35.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Pfizer Investigational Site
Baltimore, Maryland, 21208
Pfizer Investigational Site
Bismarck, North Dakota, 59501
Pfizer Investigational Site
Boise, Idaho, 83702
Pfizer Investigational Site
Burbank, California, 91506
Pfizer Investigational Site
Clementon, New Jersey, 08021
Pfizer Investigational Site
Cleveland, Ohio, 44106-5080
Pfizer Investigational Site
Clinton Township, Michigan, 48038
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Decatur, Georgia, 30030
Pfizer Investigational Site
El Centro, California, 92243
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850
Pfizer Investigational Site
Hialeah, Florida, 33013
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Kenilworth, New Jersey, 07033
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Little Rock, Alaska, 72223
Pfizer Investigational Site
Los Angeles, California, 90010
Pfizer Investigational Site
Lyndhurst, Ohio, 44124
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Middleton, Wisconsin, 53562
Pfizer Investigational Site
Midlothian, Virginia, 23112
Pfizer Investigational Site
Morristown, New Jersey, 07962
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
New Orleans, Louisiana, 70114
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Overland Park, Kansas, 66214
Pfizer Investigational Site
Owensboro, Kentucky, 42301
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Saint Paul, Minnesota, 55101
Pfizer Investigational Site
Salt Lake City, Utah, 84117
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92111
Pfizer Investigational Site
San Marcos, California, 92078
Pfizer Investigational Site
Schaumburg, Illinois, 60194
Pfizer Investigational Site
Scottsdale, Arizona, 85251
Pfizer Investigational Site
Selmer, Tennessee, 38375-1645
Pfizer Investigational Site
St. Petersburg, Florida, 33710
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
West Palm Beach, Florida, 33409
About this study
Official title: An Open-label Study to Assess the Safety and Tolerability of Xanax XR in the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.
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
- 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.
alprazolam XRDrug
Also called Xanax XR
Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days.
| Study group | Role | What they receive |
|---|---|---|
| alprazolam 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 to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall
Measured: 24 weeks
Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam
Measured: 6 week taper
The incidence of treatment-emergent adverse event during treatment with alprazolam XR
Measured: 24 weeks with taper
Secondary outcomes (5)
Descriptive estimates of the persistence of safety events and adverse events at study endpoint
Measured: 24 weeks with taper
Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores
Measured: 24 weeks
Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score
Measured: 24 weeks
Endpoint change from baseline to Week 24 in CGI-Severity score
Measured: 24 weeks
Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Measured: 24 weeks
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 startMay 2004
- Study completionOct 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT00634790
- Sponsor's protocol ID
- A6131004
- 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
- An Open-label Study to Assess the Safety and Tolerability of Xanax XR in the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
- ClinicalTrials.gov ID
- NCT00634790
- Acronym / sponsor ID
- A6131004
- Conditions
- Panic Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description for termination reason.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Oct 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 assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alprazolam 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 (2 listed)
- Subjects must meet one of the following 6 diagnoses: a. A current diagnosis of panic disorder with or without agoraphobia; b. Generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. Social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. Separation anxiety with a history of at least one panic attack in the course of their illness; e. Posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. Anxiety not otherwise specified with a history of at least one panic attack in the course of their illness.
- Educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with.
Key exclusion criteria (5 listed)
- Current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence.
- Current (in the past 3 months) diagnosis of alcohol and/or substance abuse.
- Primary diagnosis of 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 eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder.
- A Childhood Depression Rating Scale, Revised 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 |
|---|---|---|
| alprazolam XRAlso: Xanax XRAlprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days. | Drug | alprazolam group |
Primary outcome
Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall
Time frame: 24 weeks
Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam
Time frame: 6 week taper
The incidence of treatment-emergent adverse event during treatment with alprazolam XR
Time frame: 24 weeks with taper
5 secondary outcomes
Descriptive estimates of the persistence of safety events and adverse events at study endpoint
Time frame: 24 weeks with taper
Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores
Time frame: 24 weeks
Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score
Time frame: 24 weeks
Endpoint change from baseline to Week 24 in CGI-Severity score
Time frame: 24 weeks
Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Time frame: 24 weeks
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
47 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 47 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 2 inclusion and 5 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 47 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. 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 to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall (time frame: 24 weeks). The study lists 3 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.