Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00402324 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 202
- Enrollment target
NCT00402324: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00402324 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 202 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402324, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 202 participants
- Enrollment target
Study Summary
Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.
Primary Outcome
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Interventions
- DRUG placebo
- DRUG olanzapine
- DRUG divalproex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT00402324 record still lists
NCT00402324 is an interventional study that assigns participants to a tested intervention. The registered 202 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 (61% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00402324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00402324 about?
NCT00402324 is a clinical study titled "A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients". Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.
What is the current status of trial NCT00402324?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 202 participants. The study started on 2006-12. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00402324?
The interventions under investigation include: placebo (DRUG), olanzapine (DRUG), divalproex (DRUG).
Who is sponsoring clinical trial NCT00402324?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402324's enrollment target sits among peer trials
202 404th of 2000 higher than 1,595 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05272254 · 202 participants · Phase 2
Povidone Iodine Efficacy Study
- NCT05701280 · 202 participants · NA
Pilot/Pivotal Study of DBS+Rehab After Stroke
- NCT05932589 · 202 participants
Neurophysiologic Biomarkers in Rett Syndrome
- NCT06014931 · 202 participants · NA
Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia