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NCT00198094 · ClinicalTrials.gov registry record · Phase 4
A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT00198094 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 150 participants.
The verdict
NCT00198094, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG Sertraline and Alprazolam XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-12 |
| Est. Completion | 2007-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00198094
The ClinicalTrials.gov registry entry for NCT00198094 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sertraline and Alprazolam XR is the first listed.
NCT00198094 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00198094 about?
NCT00198094 is a clinical study titled "A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in 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 sympto...
What is the current status of trial NCT00198094?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2003-12. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00198094?
The interventions under investigation include: Sertraline and Alprazolam XR (DRUG).
Who is sponsoring clinical trial NCT00198094?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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