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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

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ClinicalTrials.gov Identifier: NCT01121536
Recruitment Status : Terminated (Business decision related to efficacy rather than tolerability limitations, not stopped for any safety reasons.)
First Posted : May 12, 2010
Results First Posted : January 26, 2015
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Drug: Armodafinil
Enrollment 867
Recruitment Details  
Pre-assignment Details The final visit of the double-blind study (C10953/3071, /3072, or /3073; NCT01072929, 01072630, or 01305408) serves as the enrollment visit for this study.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Period Title: Overall Study
Started 867
Safety Population 863 [1]
Full Analysis Population 859 [2]
Completed 506 [3]
Not Completed 361
Reason Not Completed
Adverse Event             63
Lack of Efficacy             35
Withdrawal by Subject             65
Protocol Violation             20
Noncompliance with study medication             12
Noncompliance with study procedures             9
Lost to Follow-up             39
Not specified             118
[1]
Participants treated
[2]
Treated participants who had at least 1 post-baseline efficacy assessment.
[3]
One participant 'completed' early due to study closeout.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Baseline Participants 867
Hide Baseline Analysis Population Description
All participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 867 participants
44.2  (10.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 867 participants
Female
525
  60.6%
Male
342
  39.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 867 participants
Hispanic or Latino
91
  10.5%
Not Hispanic or Latino
752
  86.7%
Unknown or Not Reported
24
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 867 participants
American Indian or Alaska Native
1
   0.1%
Asian
10
   1.2%
Native Hawaiian or Other Pacific Islander
1
   0.1%
Black or African American
118
  13.6%
White
709
  81.8%
More than one race
0
   0.0%
Unknown or Not Reported
28
   3.2%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 867 participants
83.7  (19.75)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 867 participants
168.8  (9.54)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 867 participants
29.4  (6.43)
1.Primary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAE)
Hide Description

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.

Time Frame Day 1 up to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 863
Measure Type: Number
Unit of Measure: participants
>=1 adverse event 423
Severe adverse event 26
Treatment-related adverse event 219
Deaths 0
Other serious adverse events 27
Withdrawn from study due to adverse events 57
Protocol-defined adverse events 19
2.Primary Outcome
Title Participants With Clinically Significant Abnormal Serum Chemistry Values
Hide Description

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
Time Frame Day 1 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with post-baseline serum chemistry assessments
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 763
Measure Type: Number
Unit of Measure: participants
>=1 clinical significant value 41
Uric Acid, M>=625, F>=506 μmol/L 17
GGT, >=3*ULN 16
ALT, >=3*ULN 7
BUN, >=10.71 mmol/L 7
AST, >=3*ULN 3
3.Primary Outcome
Title Participants With Clinically Significant Abnormal Hematology Values
Hide Description

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
Time Frame Day 1 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with post-baseline hematology assessments
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 757
Measure Type: Number
Unit of Measure: participants
>=1 clinical significant value 13
WBC, <=3*10^9/L 5
Hemoglobin, M<=115, F<=95 g/L 4
Hematocrit, M<0.37, F<0.32 L/L 8
Platelets, <=75*10^9/L 1
ANC, <=1*10^9/L 2
4.Primary Outcome
Title Participants With Clinically Significant Abnormal Urinalysis Values
Hide Description 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.
Time Frame Day 1 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with post-baseline urinalysis assessments
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 761
Measure Type: Number
Unit of Measure: participants
>=1 clinical significant value 28
Urine hemoglobin 22
Urine glucose 2
Ketones 2
Urine total protein 2
5.Primary Outcome
Title Participants With Clinically Significant Abnormal Vital Signs Values
Hide Description

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
Time Frame Day 1 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with post-baseline vital signs assessments
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 860
Measure Type: Number
Unit of Measure: participants
>=1 clinical significant value 19
Pulse high 2
Pulse low 2
Sitting systolic blood pressure high 3
Sitting systolic blood pressure low 8
Sitting diastolic blood pressure high 5
Sitting diastolic blood pressure low 2
6.Primary Outcome
Title Change From Baseline to Endpoint in Electrocardiogram (ECG) Values
Hide Description

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

Time Frame Day 0 (baseline), Month 6 or last post-baseline observation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of treated participants with both baseline and post-baseline ECG assessments
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 759
Mean (Standard Deviation)
Unit of Measure: msec
PR interval 0.2  (16.60)
QRS interval 0.0  (7.03)
QT interval 1.4  (25.66)
QTc interval Bazett 2.2  (19.50)
QTc interval Fredericia 1.9  (15.36)
RR interval -2.2  (137.98)
7.Primary Outcome
Title Physical Examination Shifts From Baseline to Endpoint
Hide Description

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

Time Frame Day 0 (baseline), Month 6 (or last post-baseline observation)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of treated participants with baseline and endpoint assessments Participants n=: General appearance 785, HEENT 784, Chest and lungs 785, Heart 785, Abdomen 785, Musculoskeletal 785, Skin 785, Lymph nodes 780, Neurological 784
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 863
Measure Type: Number
Unit of Measure: participants
General appearance; normal/normal 714
General appearance; normal/abnormal 8
General appearance; abnormal/normal 23
General appearance; abnormal/abnormal 40
HEENT: normal/normal 753
HEENT: normal/abnormal 3
HEENT: abnormal/normal 15
HEENT: abnormal/abnormal 13
Chest+lungs: normal/normal 780
Chest+lungs: normal/abnormal 0
Chest+lungs: abnormal/normal 5
Chest+lungs: abnormal/abnormal 0
Heart: normal/normal 781
Heart: normal/abnormal 2
Heart: abnormal/normal 1
Heart: abnormal/abnormal 1
Abdomen: normal/normal 751
Abdomen: normal/abnormal 5
Abdomen: abnormal/normal 16
Abdomen: abnormal/abnormal 13
Musculoskeletal: normal/normal 756
Musculoskeletal: normal/abnormal 7
Musculoskeletal: abnormal/normal 11
Musculoskeletal: abnormal/abnormal 11
Skin: normal/normal 707
Skin: normal/abnormal 9
Skin: abnormal/normal 41
Skin: abnormal/abnormal 28
Lymph nodes: normal/normal 779
Lymph nodes: normal/abnormal 0
Lymph nodes: abnormal/normal 0
Lymph nodes: abnormal/abnormal 1
Neurological: normal/normal 777
Neurological: normal/abnormal 2
Neurological: abnormal/normal 2
Neurological: abnormal/abnormal 3
8.Primary Outcome
Title Change From Baseline to Endpoint in Body Weight
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of treated participants with both baseline and post-baseline assessments.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 788
Mean (Standard Deviation)
Unit of Measure: kg
-0.8  (5.67)
9.Primary Outcome
Title Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
Hide Description

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.

Time Frame Day 0 (baseline), Month 6 or last post-baseline observation
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline (double-blind study) and treatment assessments during the open-label study.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 858
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (4.28)
10.Primary Outcome
Title Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV)
Hide Description

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

Time Frame Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; only 19 participants were asked the last three questions as the inclusion of these questions depends on physician assessment.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 863
Measure Type: Number
Unit of Measure: participants
Suicidal behavior - Actual attempt 1
Non-suicidal self-injurious behaviour 1
Suicidal behavior - Interrupted attempt 0
Suicidal behavior - Aborted attempt 0
Suicidal behavior - suicidal behavior 0
Suicidal behavior - Preparatory acts/behavior 1
Suicidal behavior - Completed suicide 0
Suicidal ideation - Wish to be dead 15
Non-specific active suicidal thoughts 4
Any methods (not plan) w/o intent to act 2
Some intent to act, w/o specific plan 1
Suicidal ideation - Specific plan and intent 1
11.Primary Outcome
Title Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
Hide Description 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.
Time Frame Day 0 (baseline), Month 6 (or last post-baseline observation)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of treated participants with both a baseline and post-baseline assessment.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 855
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.1  (7.66)
12.Primary Outcome
Title Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
Hide Description

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.

Time Frame Day 0 (baseline), Month 6 or last post-baseline observation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants with both a baseline and post-baseline assessment.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 786
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.2  (5.68)
13.Secondary Outcome
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)
Hide Description

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.

Time Frame Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 859
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (837) -23.7  (12.10)
Month 1 (793) -25.8  (11.61)
Month 2 (716) -27.6  (11.38)
Month 4 (578) -29.2  (11.68)
Month 6 (503) -29.7  (12.06)
Endpoint (857) -27.5  (13.08)
14.Secondary Outcome
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)
Hide Description

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.

Time Frame Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 859
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (838) -9.3  (4.68)
Month 1 (793) -10.0  (4.47)
Month 2 (716) -10.6  (4.52)
Month 4 (578) -11.1  (4.70)
Month 6 (503) -11.3  (4.69)
Endpoint (857) -10.6  (5.07)
15.Secondary Outcome
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
Hide Description

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.

Time Frame Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 859
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (838) -1.7  (1.17)
Month 1 (791) -1.9  (1.17)
Month 2 (716) -2.0  (1.18)
Month 4 (578) -2.2  (1.16)
Month 6 (502) -2.3  (1.18)
Endpoint (859) -2.0  (1.31)
16.Secondary Outcome
Title Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale
Hide Description

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.

Time Frame Day 0 (baseline), Month 6 or the last post-baseline assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with both a baseline and post-baseline assessment.
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
Overall Number of Participants Analyzed 779
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.7  (13.61)
Time Frame Day 1 up to 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil 150-200 mg/Day
Hide Arm/Group 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.
All-Cause Mortality
Armodafinil 150-200 mg/Day
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil 150-200 mg/Day
Affected / at Risk (%) # Events
Total   27/863 (3.13%)    
Cardiac disorders   
Angina pectoris  1  1/863 (0.12%)  1
Myocardial infarction  1  1/863 (0.12%)  1
Torsade de pointes  1  1/863 (0.12%)  1
Gastrointestinal disorders   
Colitis  1  1/863 (0.12%)  1
Diarrhoea  1  1/863 (0.12%)  1
Hepatobiliary disorders   
Cholecystitis acute  1  1/863 (0.12%)  1
Infections and infestations   
Laryngitis  1  1/863 (0.12%)  1
Pilonidal cyst  1  1/863 (0.12%)  1
Sialoadenitis  1  1/863 (0.12%)  1
Injury, poisoning and procedural complications   
Accidental overdose  1  1/863 (0.12%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/863 (0.12%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/863 (0.12%)  1
Nervous system disorders   
Transient ischaemic attack  1  1/863 (0.12%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  1/863 (0.12%)  1
Psychiatric disorders   
Acute psychosis  1  1/863 (0.12%)  1
Agitation  1  1/863 (0.12%)  1
Alcohol abuse  1  1/863 (0.12%)  1
Alcohol withdrawal syndrome  1  1/863 (0.12%)  1
Bipolar I disorder  1  3/863 (0.35%)  3
Homicidal ideation  1  1/863 (0.12%)  1
Major depression  1  1/863 (0.12%)  1
Mania  1  5/863 (0.58%)  6
Suicidal ideation  1  3/863 (0.35%)  3
Suicide attempt  1  1/863 (0.12%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/863 (0.12%)  1
Vascular disorders   
Deep vein thrombosis  1  1/863 (0.12%)  1
Hypotension  1  1/863 (0.12%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Armodafinil 150-200 mg/Day
Affected / at Risk (%) # Events
Total   133/863 (15.41%)    
Nervous system disorders   
Headache  1  96/863 (11.12%)  119
Psychiatric disorders   
Insomnia  1  49/863 (5.68%)  56
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01121536     History of Changes
Other Study ID Numbers: C10953/3074
2009-016648-38 ( EudraCT Number )
First Submitted: May 5, 2010
First Posted: May 12, 2010
Results First Submitted: January 15, 2015
Results First Posted: January 26, 2015
Last Update Posted: September 21, 2018