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NCT01038323 · ClinicalTrials.gov registry record · Phase 4
Drug and Talk Therapy for Fibromyalgia
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
NCT01038323: Completed Phase 4 study, sponsored by Indiana University.
NCT01038323 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 58 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01038323, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
Study Summary
Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers. We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).
Primary Outcome
Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)
Interventions
- OTHER CBT and milnacipran
- BEHAVIORAL CBT with a placebo
- DRUG Educational with milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
What the finished NCT01038323 record still lists
NCT01038323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which CBT and milnacipran is the first listed.
NCT01038323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01038323 about?
NCT01038323 is a clinical study titled "Drug and Talk Therapy for Fibromyalgia". Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavi...
What is the current status of trial NCT01038323?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2009-12. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01038323?
The interventions under investigation include: CBT and milnacipran (OTHER), CBT with a placebo (BEHAVIORAL), Educational with milnacipran (DRUG).
Who is sponsoring clinical trial NCT01038323?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01038323's enrollment target sits among peer trials
58 1205th of 2000 higher than 792 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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