ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

ClinicalTrials.gov ID: NCT01305408

Public ClinicalTrials.gov record NCT01305408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 7:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Study identification

NCT ID
NCT01305408
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cephalon
Industry
Enrollment
399 participants

Conditions and interventions

Conditions

Interventions

  • Armodafinil Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2011
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013
Last update posted
May 25, 2016

2011 – 2013

United States locations

U.S. sites
28
U.S. states
15
U.S. cities
24
Facility City State ZIP Site status
Teva Investigational Site 225 Birmingham Alabama
Teva Investigational Site 295 Sherman Oaks California
Teva Investigational Site 122 Temecula California
Teva Investigational Site 606 Jacksonville Beach Florida
Teva Investigational Site 127 Lauderhill Florida
Teva Investigational Site 608 Tampa Florida
Teva Investigational Site 116 Atlanta Georgia
Teva Investigational Site 205 Atlanta Georgia
Teva Investigational Site 195 Park Ridge Illinois
Teva Investigational Site 611 Indianapolis Indiana
Teva Investigational Site 600 Lafayette Indiana
Teva Investigational Site 603 Watertown Massachusetts
Teva Investigational Site 207 Brooklyn New York
Teva Investigational Site 202 New York New York
Teva Investigational Site 110 Staten Island New York
Teva Investigational Site 411 Staten Island New York
Teva Investigational Site 614 Wilmington North Carolina
Teva Investigational Site 610 Cincinnati Ohio
Teva Investigational Site 615 Toledo Ohio
Teva Investigational Site 401 Oklahoma City Oklahoma
Teva Investigational Site 609 Oklahoma City Oklahoma
Teva Investigational Site 616 Oklahoma City Oklahoma
Teva Investigational Site 406 Allentown Pennsylvania
Teva Investigational Site 403 DeSoto Texas
Teva Investigational Site 612 Friendswood Texas
Teva Investigational Site 408 Salt Lake City Utah
Teva Investigational Site 613 Kirkland Washington
Teva Investigational Site 605 Spokane Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01305408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 25, 2016 · Synced May 20, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01305408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →