Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00610610 · ClinicalTrials.gov registry record · Phase 4
Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
NCT00610610 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 120 participants.
The verdict
NCT00610610, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
Study Summary
Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
Interventions
- DRUG Placebo
- DRUG Paroxetine CR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2002-01 |
| Est. Completion | 2002-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00610610
The ClinicalTrials.gov registry entry for NCT00610610 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00610610 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00610610 about?
NCT00610610 is a clinical study titled "Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome". Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a d...
What is the current status of trial NCT00610610?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2002-01. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00610610?
The interventions under investigation include: Placebo (DRUG), Paroxetine CR (DRUG).
Who is sponsoring clinical trial NCT00610610?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.