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NCT01331304 · ClinicalTrials.gov registry record · Phase 4
Comparative Effectiveness Study for Bipolar Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 482
- Enrollment target
NCT01331304: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01331304 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 482 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331304, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 482 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of lithium and quetiapine for the treatment of individuals with bipolar disorder.
Primary Outcome
The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the mos
Interventions
- DRUG Lithium
- DRUG Quetiapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-09 |
| Phase | Phase 4 |
What the finished NCT01331304 record still lists
NCT01331304 is an interventional study that assigns participants to a tested intervention. The registered 482 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Lithium is the first listed.
NCT01331304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331304 about?
NCT01331304 is a clinical study titled "Comparative Effectiveness Study for Bipolar Disorder". The purpose of this study is to compare the effectiveness of lithium and quetiapine for the treatment of individuals with bipolar disorder.
What is the current status of trial NCT01331304?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 482 participants. The study started on 2010-09. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01331304?
The interventions under investigation include: Lithium (DRUG), Quetiapine (DRUG).
Who is sponsoring clinical trial NCT01331304?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01331304's enrollment target sits among peer trials
482 182nd of 2000 higher than 1,819 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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