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NCT01526148 · ClinicalTrials.gov registry record · Phase 4
Gao Bipolar Spectrum Lithium/Quetiapine Study
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT01526148: Clinical Trial Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
NCT01526148 is a Phase 4 study that was terminated before completion, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 42 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526148, a Phase 4 study, was terminated before completion, sponsored by University Hospitals Cleveland Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.
Primary Outcome
The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure
Interventions
- DRUG Lithium
- DRUG Quetiapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-01 |
| Phase | Phase 4 |
Why NCT01526148 stopped before completion
NCT01526148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Lithium is the first listed.
NCT01526148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01526148 about?
NCT01526148 is a clinical study titled "Gao Bipolar Spectrum Lithium/Quetiapine Study". This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar ty...
What is the current status of trial NCT01526148?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2012-01. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01526148?
The interventions under investigation include: Lithium (DRUG), Quetiapine (DRUG).
Who is sponsoring clinical trial NCT01526148?
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 NCT01526148's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 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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