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NCT00667745 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 283
- Enrollment target
NCT00667745: Completed Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
NCT00667745 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 283 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00667745, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 283 participants
- Enrollment target
Study Summary
This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
Primary Outcome
Scale: Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Construct: This scale holistically measures severity of a participant's depression, mania, and overall illness. Range: 0- not assessed, 1-normal (not at all ill), 2- borderline mentally ill, 3- mildly ill, 4- moderately ill, 5- markedly ill, 6- severely ill, 7- among the most extremely ill patients.
Interventions
- DRUG Lithium Carbonate
- DRUG Optimized Treatment (OPT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT00667745 record still lists
NCT00667745 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Lithium Carbonate is the first listed.
NCT00667745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00667745 about?
NCT00667745 is a clinical study titled "Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder". This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
What is the current status of trial NCT00667745?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 283 participants. The study started on 2008-04. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00667745?
The interventions under investigation include: Lithium Carbonate (DRUG), Optimized Treatment (OPT) (DRUG).
Who is sponsoring clinical trial NCT00667745?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00667745's enrollment target sits among peer trials
283 303rd of 2000 higher than 1,698 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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