Panic DisorderPhase 4NCT00198094
A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
A Phase 4 study testing Sertraline and Alprazolam XR in people with Panic Disorder, run by Indiana University at 3 sites in United States.
Trial summary
The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Sertraline and Alprazolam XR
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2003to Sep 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will include men and women over the age of eighteen;
- the ability to give written informed consent;
- current principal or co-principal psychiatric diagnosis of panic disorder with or without agoraphobia based on DSM-IV criteria (American Psychiatric Association, 1994);
- willing to use an effective means of contraception;
- free of psychoactive medications for at least 2 weeks prior to study enrollment;
- not actively be suicidal.
Who cannot join
- actively suicidal;
- medical conditions for which either sertraline or alprazolam XR would be contraindicated;
- recent six month history of substance or alcohol abuse;
- history or presence of psychotic or bipolar disorder;
- women who are pregnant or breastfeeding;
- history or presence of a seizure disorder or a known history of more than one childhood febrile seizure;
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- presence of a personality disorder severe enough to compromise the investigator's ability to evaluate the efficacy and safety of the study medication;
- concomitant therapy with other psychotropic medication(s);
- clinically significant abnormality during physical examination, vital signs, EKG, urine drug screen, or laboratory tests at the screen visit.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospital Outpatient Center, Psychiatry
Indianapolis, Indiana, 46202
University of Pennsylvania, Mood and Anxiety Disorders Section
Philadelphia, Pennsylvania, 19104-3309
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, 33613
About this study
Official title: A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients
The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.
- Conditions
- Panic Disorder
- Being tested
- Sertraline and 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.
Sertraline and Alprazolam XRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Panic symptoms scale score
CGI-I
CGI-S
Secondary outcomes (1)
Sheehan Disability Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, University of Pennsylvania, University of South Florida
- Investigators
- Andrew W Goddard, M.D., Principal investigator, Indiana UniversityKarl Rickles, M.D., Principal investigator, University of PennsylvaniaDavid Sheehan, M.D., M.B.A., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198094
- Sponsor's protocol ID
- 0311-34
- Other IDs
- IU 1003
- Status last verified
- Oct 2007
- First submitted
- 12 Sep 2005
- Last updated
- 22 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
A randomized double-blind comparison of sertraline with early alprazolam XR Co-administration vs. sertraline/placebo for panic disorder. Goddard AW, Ball SG, Hastings AK, Shekhar A, Rickels K, Rynn M, Janavs J, Sheehan DV. BIOLOGICAL PSYCHIATRY 57 (8): 62S-62S 220 Suppl. S, APR 15 2005. IDS Number: 915VE ISSN: 0006-3223
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients
- ClinicalTrials.gov ID
- NCT00198094
- Acronym / sponsor ID
- 0311-34
- Conditions
- Panic Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Pfizer, University of Pennsylvania, University of South Florida
- Study start
- Dec 2003
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Sep 2005 (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 primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will include men and women over the age of eighteen;
- the ability to give written informed consent;
- current principal or co-principal psychiatric diagnosis of panic disorder with or without agoraphobia based on DSM-IV criteria (American Psychiatric Association, 1994);
- willing to use an effective means of contraception;
- free of psychoactive medications for at least 2 weeks prior to study enrollment;
Key exclusion criteria (9 listed)
- actively suicidal;
- medical conditions for which either sertraline or alprazolam XR would be contraindicated;
- recent six month history of substance or alcohol abuse;
- history or presence of psychotic or bipolar disorder;
- women who are pregnant or breastfeeding;
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 |
|---|---|---|
| Sertraline and Alprazolam XR | Drug | – |
Primary outcome
Panic symptoms scale score
CGI-I
CGI-S
1 secondary outcome
Sheehan Disability Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2007.
- Results publicationA randomized double-blind comparison of sertraline with early alprazolam XR Co-administration vs. sertraline/placebo for panic disorder. Goddard AW, Ball SG, Hastings AK, Shekhar A, Rickels K, Rynn M, Janavs J, Sheehan DV. BIOLOGICAL PSYCHIATRY 57 (8): 62S-62S 220 Suppl. S, APR 15 2005. IDS Number: 915VE ISSN: 0006-3223
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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.
Andrew W Goddard, M.D. principal investigator
Indiana University
Karl Rickles, M.D. principal investigator
University of Pennsylvania
David Sheehan, M.D., M.B.A. principal investigator
University of South Florida
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 Sertraline and Alprazolam XR in people with Panic Disorder, run by Indiana University 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 22 Oct 2007. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Panic symptoms scale score. 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?
On the ClinicalTrials.gov record for NCT00198094, which also lists 1 linked publication.
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 22 Oct 2007.