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NCT00835120 · ClinicalTrials.gov registry record · Phase 4
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT00835120: Completed Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
NCT00835120 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835120, a Phase 4 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.
Primary Outcome
Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
Interventions
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
What the finished NCT00835120 record still lists
NCT00835120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Pioglitazone is the first listed.
NCT00835120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835120 about?
NCT00835120 is a clinical study titled "Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance". The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 wee...
What is the current status of trial NCT00835120?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2009-03. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00835120?
The interventions under investigation include: Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT00835120?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835120's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 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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