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NCT01121536 · ClinicalTrials.gov registry record · Phase 3
Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
A Phase 3 study, sponsored by Cephalon.
- Terminated
- Registry status
- Phase 3
- Development phase
- 867
- Enrollment target
NCT01121536: Clinical Trial Phase 3 study, sponsored by Cephalon.
NCT01121536 is a Phase 3 study that was terminated before completion, run by Cephalon. The registered enrollment target is 867 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121536, a Phase 3 study, was terminated before completion, sponsored by Cephalon.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 867 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.
Primary Outcome
AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring
Interventions
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 867 participants |
| Start Date | 2010-04-30 |
| Est. Completion | 2013-10-31 |
| Phase | Phase 3 |
Why NCT01121536 stopped before completion
NCT01121536 is an interventional study that assigns participants to a tested intervention. The registered 867 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 1 intervention - of which Armodafinil is the first listed.
NCT01121536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01121536 about?
NCT01121536 is a clinical study titled "Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder". The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.
What is the current status of trial NCT01121536?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 867 participants. The study started on 2010-04-30. Estimated completion is 2013-10-31.
What interventions are being tested in trial NCT01121536?
The interventions under investigation include: Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01121536?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01121536's enrollment target sits among peer trials
867 376th of 2000 higher than 1,625 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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