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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 is a Phase 4 study that was terminated before completion, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 42 participants.
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.
Interventions
- DRUG Lithium
- DRUG Quetiapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01526148
The ClinicalTrials.gov registry entry for NCT01526148 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lithium is the first listed.
NCT01526148 reports 0 study locations.
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.
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