Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00044616 · ClinicalTrials.gov registry record · Phase 4
Relapse Prevention for Bipolar Type-II Disorder
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
NCT00044616: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT00044616 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 180 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00044616, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
Study Summary
This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder.
Interventions
- DRUG Lithium
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2001-02 |
| Est. Completion | 2007-01 |
| Phase | Phase 4 |
What the finished NCT00044616 record still lists
NCT00044616 is an interventional study that assigns participants to a tested intervention. The registered 180 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Lithium is the first listed.
NCT00044616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00044616 about?
NCT00044616 is a clinical study titled "Relapse Prevention for Bipolar Type-II Disorder". This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder.
What is the current status of trial NCT00044616?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2001-02. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00044616?
The interventions under investigation include: Lithium (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00044616?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00044616's enrollment target sits among peer trials
180 466th of 2000 higher than 1,525 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
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
- NCT03384563 · 180 participants · Phase 4
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
- NCT03423628 · 180 participants · Phase 1
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
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