Panic DisorderPhase 4NCT00635076
A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) 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 3 sites in United States.
Trial 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. 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
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 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 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.
Who cannot join
- Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Middleton, Wisconsin, 53562
Pfizer Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Continuation Treatment With Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder
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.
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
Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
alprazolam XRDrug
Also called Xanax 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.
| 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.
Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
Measured: 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
Measured: Weeks 6, 8, 12, 16, 20, and 24
Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
Measured: Week 24
Secondary outcomes (6)
Endpoint change from baseline in Hamilton Anxiety Rating scale
Measured: Weeks 12 and 24
Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores
Measured: Weeks 12 an 24
Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale
Measured: Weeks 12 and 24
Endpoint change compared with baseline in CGI-Severity score
Measured: Weeks 12 and 24
Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Measured: Weeks 12 and 24
Descriptive estimates of the persistence of safety events and adverse events
Measured: Week 24
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 startJul 2004
- Study completionSep 2004
Why it stopped: Please see Detailed Description for the 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
- 3 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
- NCT00635076
- Sponsor's protocol ID
- A6131007
- 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 Continuation Treatment With Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder
- ClinicalTrials.gov ID
- NCT00635076
- Acronym / sponsor ID
- A6131007
- Conditions
- Panic Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description for the termination reason.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 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 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.
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 (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.
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 |
|---|---|---|
| placeboPatients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily). | Other | Placebo group |
| alprazolam XRAlso: Xanax XRPatients 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. | Drug | Alprazolam XR group |
Primary outcome
Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
Time frame: 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
Time frame: Weeks 6, 8, 12, 16, 20, and 24
Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
Time frame: Week 24
6 secondary outcomes
Endpoint change from baseline in Hamilton Anxiety Rating scale
Time frame: Weeks 12 and 24
Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores
Time frame: Weeks 12 an 24
Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale
Time frame: Weeks 12 and 24
Endpoint change compared with baseline in CGI-Severity score
Time frame: Weeks 12 and 24
Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Time frame: Weeks 12 and 24
Descriptive estimates of the persistence of safety events and adverse events
Time frame: Week 24
Results and safety
The study was stopped early (reason given: Please see Detailed Description for the 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
3 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 3 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 3 inclusion and 1 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 3 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 the 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?
Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam (time frame: Week 24 (taper baseline), Weeks 25-29, and end of taper visit). 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.