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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 is a Phase 3 study that was terminated before completion, run by Cephalon. The registered enrollment target is 867 participants.
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.
Interventions
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 867 participants |
| Start Date | 2010-04-30 |
| Est. Completion | 2013-10-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01121536
The ClinicalTrials.gov registry entry for NCT01121536 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 867 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Armodafinil is the first listed.
NCT01121536 reports 0 study locations.
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.
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