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Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Primary Purpose

Depression

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Armodafinil

About this trial

This is an interventional treatment trial for Depression focused on measuring Bipolar I Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.
During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
1. The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
2. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.
3. The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s).
4. The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator.
The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.

Key Exclusion Criteria:

The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
The patient has psychotic symptoms or had psychosis during the double-blind study.
The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Armodafinil 150-200 mg/day

Arm Description

Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.

Outcomes

Primary Outcome Measures

Participants With Treatment-Emergent Adverse Events (TEAE)

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 expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.

Participants With Clinically Significant Abnormal Serum Chemistry Values

Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. ULN=upper limit of normal BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women. GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L ALT = alanine aminotransferase with a normal range of 6-43 U/L BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L AST = aspartate aminotransferase with a normal range of 9-36 U/L

Participants With Clinically Significant Abnormal Hematology Values

Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. ULN=upper limit of normal WBC - white blood cell counts with a normal range of 3.8-10.7 10^9/L. Hemoglobin with a normal range of 115-181 g/L Hematocrit with a normal range of 0.34-0.54 L/L Platelet counts with a normal range of 130-400 10^9/L ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10^9/L

Participants With Clinically Significant Abnormal Urinalysis Values

Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was >=2 unit increase from baseline.

Participants With Clinically Significant Abnormal Vital Signs Values

Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria: Pulse high: >=120 beats per minute (bpm) and increase of >=15 bpm from baseline Pulse low: <=50 bpm and decrease of >=15 bpm from baseline Sitting systolic blood pressure high: >=180 mm Hg and increase of >=20 mm Hg from baseline Sitting systolic blood pressure low: <=90 mm Hg and decrease of >=20 mm Hg from baseline Sitting diastolic blood pressure high: >=105 mm Hg and increase of >=15 mm Hg from baseline Sitting diastolic blood pressure low: <=50 mm Hg and decrease of >=15 mm Hg from baseline

Change From Baseline to Endpoint in Electrocardiogram (ECG) Values

ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination). RR= inter-beat intervals

Physical Examination Shifts From Baseline to Endpoint

Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint. HEENT = Head, Eye, Ear, Nose and Throat exam

Change From Baseline to Endpoint in Body Weight

Baseline was the score before the first dose of study drug in the double-blind study.

Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. Baseline was the score before the first dose of study drug in the double-blind study.

Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated. - C-SSRS=Columbia Suicide Severity Rating Scale

Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. Baseline was the assessment before the first dose of study drug in the double-blind study.

Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety. Baseline was the score before the first dose of study drug in the double-blind study.

Secondary Outcome Measures

Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. Baseline was the score before the first dose of study drug in the double-blind study.

Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. Baseline was the score before the first dose of study drug in the double-blind study.

Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression

The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression. Baseline was the score before the first dose of study drug in the double-blind study.

Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning. Baseline was the score before the first dose of study drug in the double-blind study.

Full Information

NCT ID

NCT01121536

First Posted

May 5, 2010

Last Updated

August 23, 2018

Sponsor

Cephalon

1. Study Identification

Unique Protocol Identification Number

NCT01121536

Brief Title

Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Official Title

A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Business decision related to efficacy rather than tolerability limitations, not stopped for any safety reasons.

Study Start Date

April 30, 2010 (Actual)

Primary Completion Date

October 31, 2013 (Actual)

Study Completion Date

October 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cephalon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Bipolar I Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

867 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Armodafinil 150-200 mg/day

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Armodafinil

Other Intervention Name(s)

CEP-10953, Nuvigil

Intervention Description

Armodafinil tablets, taken orally, once daily in the morning

Primary Outcome Measure Information:

Title

Participants With Treatment-Emergent Adverse Events (TEAE)

Description

Time Frame

Day 1 up to Month 6

Title

Participants With Clinically Significant Abnormal Serum Chemistry Values

Description

Time Frame

Day 1 to Month 6

Title

Participants With Clinically Significant Abnormal Hematology Values

Description

Time Frame

Day 1 to Month 6

Title

Participants With Clinically Significant Abnormal Urinalysis Values

Description

Time Frame

Day 1 to Month 6

Title

Participants With Clinically Significant Abnormal Vital Signs Values

Description

Time Frame

Day 1 to Month 6

Title

Change From Baseline to Endpoint in Electrocardiogram (ECG) Values

Description

Time Frame

Day 0 (baseline), Month 6 or last post-baseline observation

Title

Physical Examination Shifts From Baseline to Endpoint

Description

Time Frame

Day 0 (baseline), Month 6 (or last post-baseline observation)

Title

Change From Baseline to Endpoint in Body Weight

Description

Baseline was the score before the first dose of study drug in the double-blind study.

Time Frame

Day 0 (baseline), Month 6 (or last post-baseline observation)

Title

Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

Description

Time Frame

Day 0 (baseline), Month 6 or last post-baseline observation

Title

Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)

Description

Time Frame

Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit

Title

Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

Description

Time Frame

Day 0 (baseline), Month 6 (or last post-baseline observation)

Title

Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

Description

Time Frame

Day 0 (baseline), Month 6 or last post-baseline observation

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

Description

Time Frame

Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)

Title

Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

Description

Time Frame

Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)

Title

Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression

Description

Time Frame

Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)

Title

Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale

Description

Time Frame

Day 0 (baseline), Month 6 or the last post-baseline assessment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder. The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression. During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met: The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine. The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s). The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator. The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment. Key Exclusion Criteria: The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study. The patient has psychotic symptoms or had psychosis during the double-blind study. The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study. The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sponsor's Medical Expert

Organizational Affiliation

Cephalon

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 113

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Teva Investigational Site 225

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35226

Country

United States

Facility Name

Teva Investigational Site 229

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

Teva Investigational Site 217

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

Facility Name

Teva Investigational Site 223

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

Facility Name

Teva Investigational Site 115

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Teva Investigational Site 121

City

Imperial

State/Province

California

ZIP/Postal Code

92251

Country

United States

Facility Name

Teva Investigational Site 303

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Teva Investigational Site 400

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Teva Investigational Site 200

City

Pico Rivera

State/Province

California

ZIP/Postal Code

90660

Country

United States

Facility Name

Teva Investigational Site 128

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Teva Investigational Site 201

City

San Diego

State/Province

California

ZIP/Postal Code

92126

Country

United States

Facility Name

Teva Investigational Site 192

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Teva Investigational Site 292

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Teva Investigational Site 295

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Teva Investigational Site 122

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Facility Name

Teva Investigational Site 131

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Teva Investigational Site 606

City

Jacksonville Beach

State/Province

Florida

ZIP/Postal Code

32250

Country

United States

Facility Name

Teva Investigational Site 132

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Teva Investigational Site 127

City

Lauderhill

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Teva Investigational Site 119

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

Teva Investigational Site 118

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Teva Investigational Site 608

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Teva Investigational Site 205

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Teva Investigational Site 116

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Teva Investigational Site 204

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30080

Country

United States

Facility Name

Teva Investigational Site 107

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Facility Name

Teva Investigational Site 301

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Facility Name

Teva Investigational Site 219

City

Oakbrook Terrace

State/Province

Illinois

ZIP/Postal Code

60181

Country

United States

Facility Name

Teva Investigational Site 195

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Teva Investigational Site 600

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

Teva Investigational Site 300

City

Pikesville

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Teva Investigational Site 603

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Teva Investigational Site 290

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Teva Investigational Site 133

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63139

Country

United States

Facility Name

Teva Investigational Site 103

City

Mount Laurel

State/Province

New Jersey

ZIP/Postal Code

08054

Country

United States

Facility Name

Teva Investigational Site 212

City

Mount Laurel

State/Province

New Jersey

ZIP/Postal Code

08054

Country

United States

Facility Name

Teva Investigational Site 193

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Teva Investigational Site 207

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

Teva Investigational Site 104

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

Teva Investigational Site 202

City

New York

State/Province

New York

ZIP/Postal Code

10023

Country

United States

Facility Name

Teva Investigational Site 129

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Teva Investigational Site 411

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

Teva Investigational Site 110

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Teva Investigational Site 105

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Teva Investigational Site 190

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44125

Country

United States

Facility Name

Teva Investigational Site 213

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Teva Investigational Site 610

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Teva Investigational Site 102

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Teva Investigational Site 401

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Teva Investigational Site 609

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Teva Investigational Site 616

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Teva Investigational Site 406

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

Teva Investigational Site 117

City

Media

State/Province

Pennsylvania

ZIP/Postal Code

19063

Country

United States

Facility Name

Teva Investigational Site 106

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Teva Investigational Site 111

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

Teva Investigational Site 403

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Teva Investigational Site 612

City

Friendswood

State/Province

Texas

ZIP/Postal Code

77546

Country

United States

Facility Name

Teva Investigational Site 228

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Teva Investigational Site 224

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

Facility Name

Teva Investigational Site 409

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Teva Investigational Site 408

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Teva Investigational Site 404

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Teva Investigational Site 100

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Teva Investigational Site 613

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

Teva Investigational Site 605

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Teva Investigational Site 237

City

Buenos Aires

ZIP/Postal Code

1428

Country

Argentina

Facility Name

Teva Investigational Site 450

City

Buenos Aires

ZIP/Postal Code

C1012AAU

Country

Argentina

Facility Name

Teva Investigational Site 881

City

Buenos Aires

ZIP/Postal Code

C1058AAJ

Country

Argentina

Facility Name

Teva Investigational Site 884

City

Buenos Aires

ZIP/Postal Code

C1117ABH

Country

Argentina

Facility Name

Teva Investigational Site 136

City

Buenos Aires

ZIP/Postal Code

C1405BOA

Country

Argentina

Facility Name

Teva Investigational Site 134

City

Buenos Aires

ZIP/Postal Code

C1425AHQ

Country

Argentina

Facility Name

Teva Investigational Site 235

City

Buenos Aires

ZIP/Postal Code

C1425CDC

Country

Argentina

Facility Name

Teva Investigational Site 462

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 135

City

Cordoba

ZIP/Postal Code

5004ALB

Country

Argentina

Facility Name

Teva Investigational Site 236

City

Cordoba

ZIP/Postal Code

X5009BIN

Country

Argentina

Facility Name

Teva Investigational Site 138

City

La Plata, Buenos Aires

ZIP/Postal Code

01900

Country

Argentina

Facility Name

Teva Investigational Site 371

City

La Plata

ZIP/Postal Code

41515

Country

Argentina

Facility Name

Teva Investigational Site 238

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Teva Investigational Site 141

City

Brisbane

ZIP/Postal Code

4053

Country

Australia

Facility Name

Teva Investigational Site 240

City

Malvern

ZIP/Postal Code

3144

Country

Australia

Facility Name

Teva Investigational Site 624

City

Rio de Janeiro

ZIP/Postal Code

22270-060

Country

Brazil

Facility Name

Teva Investigational Site 248

City

Bourgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Teva Investigational Site 146

City

Kardzhali

ZIP/Postal Code

06600

Country

Bulgaria

Facility Name

Teva Investigational Site 148

City

Kazanlak

ZIP/Postal Code

6100

Country

Bulgaria

Facility Name

Teva Investigational Site 853

City

Pazardjik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

Teva Investigational Site 852

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Teva Investigational Site 249

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Teva Investigational Site 145

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Teva Investigational Site 370

City

Ruse

ZIP/Postal Code

7003

Country

Bulgaria

Facility Name

Teva Investigational Site 147

City

Sofia

ZIP/Postal Code

1377

Country

Bulgaria

Facility Name

Teva Investigational Site 854

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Teva Investigational Site 855

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Teva Investigational Site 247

City

Sofia

ZIP/Postal Code

1632

Country

Bulgaria

Facility Name

Teva Investigational Site 851

City

Varna

ZIP/Postal Code

9002

Country

Bulgaria

Facility Name

Teva Investigational Site 245

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Teva Investigational Site 198

City

Kelowna

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

Teva Investigational Site 296

City

Mississauga

ZIP/Postal Code

L5M 4N4

Country

Canada

Facility Name

Teva Investigational Site 196

City

Mississauga

ZIP/Postal Code

L5M4N4

Country

Canada

Facility Name

Teva Investigational Site 299

City

Penticton

ZIP/Postal Code

V2A 4M4

Country

Canada

Facility Name

Teva Investigational Site 635

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Teva Investigational Site 633

City

Zagreb

ZIP/Postal Code

10090

Country

Croatia

Facility Name

Teva Investigational Site 634

City

Zagreb

ZIP/Postal Code

10090

Country

Croatia

Facility Name

Teva Investigational Site 286

City

Dole

ZIP/Postal Code

39100

Country

France

Facility Name

Teva Investigational Site 153

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Teva Investigational Site 655

City

Achim

ZIP/Postal Code

28832

Country

Germany

Facility Name

Teva Investigational Site 651

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Teva Investigational Site 661

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

Teva Investigational Site 664

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Teva Investigational Site 662

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Teva Investigational Site 666

City

Nagykallo

ZIP/Postal Code

4321

Country

Hungary

Facility Name

Teva Investigational Site 688

City

Catania

ZIP/Postal Code

95124

Country

Italy

Facility Name

Teva Investigational Site 689

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Teva Investigational Site 687

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Teva Investigational Site 692

City

Rome

ZIP/Postal Code

00193

Country

Italy

Facility Name

Teva Investigational Site 259

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Teva Investigational Site 258

City

Gdansk

ZIP/Postal Code

80-282

Country

Poland

Facility Name

Teva Investigational Site 257

City

Gdansk

ZIP/Postal Code

80952

Country

Poland

Facility Name

Teva Investigational Site 156

City

Kielce

ZIP/Postal Code

25-317

Country

Poland

Facility Name

Teva Investigational Site 155

City

Krakow

ZIP/Postal Code

31-526

Country

Poland

Facility Name

Teva Investigational Site 256

City

Leszno

ZIP/Postal Code

64-100

Country

Poland

Facility Name

Teva Investigational Site 255

City

Skorzewo

ZIP/Postal Code

60-185

Country

Poland

Facility Name

Teva Investigational Site 861

City

Szczecin

ZIP/Postal Code

71-460

Country

Poland

Facility Name

Teva Investigational Site 157

City

Tuszyn

ZIP/Postal Code

95-080

Country

Poland

Facility Name

Teva Investigational Site 832

City

Belgrade

ZIP/Postal Code

11 000

Country

Serbia

Facility Name

Teva Investigational Site 175

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 177

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 831

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 833

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 176

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Teva Investigational Site 837

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Teva Investigational Site 834

City

Novi Knezevac

ZIP/Postal Code

23330

Country

Serbia

Facility Name

Teva Investigational Site 699

City

Bratislava

ZIP/Postal Code

82007

Country

Slovakia

Facility Name

Teva Investigational Site 697

City

Rimavska Sobota

ZIP/Postal Code

97901

Country

Slovakia

Facility Name

Teva Investigational Site 696

City

Roznava

ZIP/Postal Code

04801

Country

Slovakia

Facility Name

Teva Investigational Site 698

City

Trencin

ZIP/Postal Code

91101

Country

Slovakia

Facility Name

Teva Investigational Site 712

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Teva Investigational Site 709

City

Cape Town

ZIP/Postal Code

7708

Country

South Africa

Facility Name

Teva Investigational Site 708

City

Centurion

ZIP/Postal Code

0046

Country

South Africa

Facility Name

Teva Investigational Site 710

City

Johannesburg

ZIP/Postal Code

2195

Country

South Africa

Facility Name

Teva Investigational Site 711

City

Paarl

ZIP/Postal Code

7646

Country

South Africa

Facility Name

Teva Investigational Site 706

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Teva Investigational Site 336

City

Alcoy

ZIP/Postal Code

03804

Country

Spain

Facility Name

Teva Investigational Site 434

City

Coslada (Madrid)

ZIP/Postal Code

28822

Country

Spain

Facility Name

Teva Investigational Site 430

City

Vitoria-Gasteiz

ZIP/Postal Code

01006

Country

Spain

Facility Name

Teva Investigational Site 433

City

Vitoria

ZIP/Postal Code

01004

Country

Spain

Facility Name

Teva Investigational Site 181

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Teva Investigational Site 872

City

Donetsk

ZIP/Postal Code

83099

Country

Ukraine

Facility Name

Teva Investigational Site 282

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Teva Investigational Site 281

City

Kiev

ZIP/Postal Code

4080

Country

Ukraine

Facility Name

Teva Investigational Site 180

City

Lugansk

ZIP/Postal Code

91045

Country

Ukraine

Facility Name

Teva Investigational Site 873

City

Lviv

ZIP/Postal Code

79012

Country

Ukraine

Facility Name

Teva Investigational Site 280

City

Odessa

ZIP/Postal Code

65014

Country

Ukraine

Facility Name

Teva Investigational Site 875

City

Odessa

ZIP/Postal Code

65014

Country

Ukraine

Facility Name

Teva Investigational Site 183

City

Poltava

ZIP/Postal Code

36006

Country

Ukraine

Facility Name

Teva Investigational Site 871

City

S. Oleksandrivka

ZIP/Postal Code

65128

Country

Ukraine

Facility Name

Teva Investigational Site 184

City

Simferopol

ZIP/Postal Code

95006

Country

Ukraine

Facility Name

Teva Investigational Site 182

City

Vinnytsya

ZIP/Postal Code

21018

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Depression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial