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NCT01072630 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
A Phase 3 study of Depression, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 492
- Enrollment target
- 20
- Study locations
NCT01072630 is a Phase 3 study of Depression that has completed, run by Cephalon. The registered enrollment target is 492 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT01072630, a Phase 3 study of Depression, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 492 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Armodafinil
Study Locations (20)
California
- South Coast Medical Associates/SC Clinical Trials, Inc. - Anaheim
- Comprehensive NeuroScience - Cerritos
- Sun Valley Behavioral Medical - Imperial
- North County Clinical Research - Oceanside
- CNRI Los Angeles LLC - Pico Rivera
- CNRI-San Diego LLC - San Diego
- Clinical Innovations Inc. - Santa Ana
- Schuster Medical Research Institute - Sherman Oaks
- Stanford University Medical Center - Stanford
- Viking Clinical Research Center - Temecula
Florida
- Scientific Clinical Research, Inc. - Aventura
- Florida Clinical Research Center - Bradenton
- Clinical Neuroscience Solutions Inc - Jacksonville
- Fidelity Clinical Research - Lauderhill
- Compass Research, LLC - Orlando
- Stedman Clinical Trials, LLC - Tampa
Georgia
- Atlanta Center for Medical Research - Atlanta
- Carman Research - Smyrna
Alabama
- Birmingham Psychiatry Pharmaceutical Studies, Inc - Birmingham
District of Columbia
- Comprehensive NeuroScience - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 492 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01072630
The ClinicalTrials.gov registry entry for NCT01072630 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 492 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (37% lower). The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01072630 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01072630 about?
NCT01072630 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder". The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
What is the current status of trial NCT01072630?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 492 participants. The study started on 2010-03. Estimated completion is 2012-11.
What conditions does trial NCT01072630 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT01072630?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01072630?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01072630 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.