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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Armodafinil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 867 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2010
Actual Primary Completion Date : October 31, 2013
Actual Study Completion Date : October 31, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Armodafinil 150-200 mg/day
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.
Drug: Armodafinil
Armodafinil tablets, taken orally, once daily in the morning
Other Names:
  • CEP-10953
  • Nuvigil




Primary Outcome Measures :
  1. Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Day 1 up to Month 6 ]

    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.


  2. Participants With Clinically Significant Abnormal Serum Chemistry Values [ Time Frame: Day 1 to Month 6 ]

    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

  3. Participants With Clinically Significant Abnormal Hematology Values [ Time Frame: Day 1 to Month 6 ]

    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

  4. Participants With Clinically Significant Abnormal Urinalysis Values [ Time Frame: Day 1 to Month 6 ]
    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.

  5. Participants With Clinically Significant Abnormal Vital Signs Values [ Time Frame: Day 1 to Month 6 ]

    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

  6. Change From Baseline to Endpoint in Electrocardiogram (ECG) Values [ Time Frame: Day 0 (baseline), Month 6 or last post-baseline observation ]

    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


  7. Physical Examination Shifts From Baseline to Endpoint [ Time Frame: Day 0 (baseline), Month 6 (or last post-baseline observation) ]

    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


  8. Change From Baseline to Endpoint in Body Weight [ Time Frame: Day 0 (baseline), Month 6 (or last post-baseline observation) ]
    Baseline was the score before the first dose of study drug in the double-blind study.

  9. Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score [ Time Frame: Day 0 (baseline), Month 6 or last post-baseline observation ]

    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.


  10. Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) [ Time Frame: Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit ]

    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


  11. Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score [ Time Frame: Day 0 (baseline), Month 6 (or last post-baseline observation) ]
    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.

  12. Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score [ Time Frame: Day 0 (baseline), Month 6 or last post-baseline observation ]

    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 :
  1. 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) [ Time Frame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment) ]

    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.


  2. 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) [ Time Frame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment) ]

    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.


  3. 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 [ Time Frame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment) ]

    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.


  4. Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale [ Time Frame: Day 0 (baseline), Month 6 or the last post-baseline assessment) ]

    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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121536


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Locations
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United States, Alabama
Teva Investigational Site 113
Birmingham, Alabama, United States, 35216
Teva Investigational Site 225
Birmingham, Alabama, United States, 35226
United States, California
Teva Investigational Site 229
Anaheim, California, United States, 92804
Teva Investigational Site 217
Cerritos, California, United States, 90703
Teva Investigational Site 223
Cerritos, California, United States, 90703
Teva Investigational Site 115
Garden Grove, California, United States, 92845
Teva Investigational Site 121
Imperial, California, United States, 92251
Teva Investigational Site 303
Oceanside, California, United States, 92056
Teva Investigational Site 400
Oceanside, California, United States, 92056
Teva Investigational Site 200
Pico Rivera, California, United States, 90660
Teva Investigational Site 128
San Diego, California, United States, 92123
Teva Investigational Site 201
San Diego, California, United States, 92126
Teva Investigational Site 192
Santa Ana, California, United States, 92705
Teva Investigational Site 292
Santa Ana, California, United States, 92705
Teva Investigational Site 295
Sherman Oaks, California, United States, 91403
Teva Investigational Site 122
Temecula, California, United States, 92591
United States, Florida
Teva Investigational Site 131
Gainesville, Florida, United States, 32607
Teva Investigational Site 606
Jacksonville Beach, Florida, United States, 32250
Teva Investigational Site 132
Jacksonville, Florida, United States, 32256
Teva Investigational Site 127
Lauderhill, Florida, United States, 33319
Teva Investigational Site 119
North Miami, Florida, United States, 33161
Teva Investigational Site 118
Tampa, Florida, United States, 33613
Teva Investigational Site 608
Tampa, Florida, United States, 33613
United States, Georgia
Teva Investigational Site 205
Atlanta, Georgia, United States, 30308
Teva Investigational Site 116
Atlanta, Georgia, United States, 30328
Teva Investigational Site 204
Smyrna, Georgia, United States, 30080
United States, Illinois
Teva Investigational Site 107
Naperville, Illinois, United States, 60563
Teva Investigational Site 301
Naperville, Illinois, United States, 60563
Teva Investigational Site 219
Oakbrook Terrace, Illinois, United States, 60181
Teva Investigational Site 195
Park Ridge, Illinois, United States, 60068
United States, Indiana
Teva Investigational Site 600
Lafayette, Indiana, United States, 47905
United States, Maryland
Teva Investigational Site 300
Pikesville, Maryland, United States, 21208
United States, Massachusetts
Teva Investigational Site 603
Watertown, Massachusetts, United States, 02472
United States, Mississippi
Teva Investigational Site 290
Flowood, Mississippi, United States, 39232
United States, Missouri
Teva Investigational Site 133
Saint Louis, Missouri, United States, 63139
United States, New Jersey
Teva Investigational Site 103
Mount Laurel, New Jersey, United States, 08054
Teva Investigational Site 212
Mount Laurel, New Jersey, United States, 08054
United States, New Mexico
Teva Investigational Site 193
Albuquerque, New Mexico, United States, 87109
United States, New York
Teva Investigational Site 207
Brooklyn, New York, United States, 11201
Teva Investigational Site 104
Brooklyn, New York, United States, 11235
Teva Investigational Site 202
New York, New York, United States, 10023
Teva Investigational Site 129
Rochester, New York, United States, 14618
Teva Investigational Site 411
Staten Island, New York, United States, 10305
Teva Investigational Site 110
Staten Island, New York, United States, 10312
United States, North Carolina
Teva Investigational Site 105
Raleigh, North Carolina, United States, 27609
United States, Ohio
Teva Investigational Site 190
Beachwood, Ohio, United States, 44125
Teva Investigational Site 213
Canton, Ohio, United States, 44718
Teva Investigational Site 610
Cincinnati, Ohio, United States, 45267
Teva Investigational Site 102
Dayton, Ohio, United States, 45408
United States, Oklahoma
Teva Investigational Site 401
Oklahoma City, Oklahoma, United States, 73103
Teva Investigational Site 609
Oklahoma City, Oklahoma, United States, 73112
Teva Investigational Site 616
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Teva Investigational Site 406
Allentown, Pennsylvania, United States, 18104
Teva Investigational Site 117
Media, Pennsylvania, United States, 19063
United States, Tennessee
Teva Investigational Site 106
Memphis, Tennessee, United States, 38119
United States, Texas
Teva Investigational Site 111
Austin, Texas, United States, 78756
Teva Investigational Site 403
DeSoto, Texas, United States, 75115
Teva Investigational Site 612
Friendswood, Texas, United States, 77546
Teva Investigational Site 228
Houston, Texas, United States, 77090
Teva Investigational Site 224
Irving, Texas, United States, 75062
United States, Utah
Teva Investigational Site 409
Orem, Utah, United States, 84058
Teva Investigational Site 408
Salt Lake City, Utah, United States, 84107
United States, Virginia
Teva Investigational Site 404
Richmond, Virginia, United States, 23230
United States, Washington
Teva Investigational Site 100
Bellevue, Washington, United States, 98007
Teva Investigational Site 613
Kirkland, Washington, United States, 98033
Teva Investigational Site 605
Spokane, Washington, United States, 99204
Argentina
Teva Investigational Site 237
Buenos Aires, Argentina, 1428
Teva Investigational Site 450
Buenos Aires, Argentina, C1012AAU
Teva Investigational Site 881
Buenos Aires, Argentina, C1058AAJ
Teva Investigational Site 884
Buenos Aires, Argentina, C1117ABH
Teva Investigational Site 136
Buenos Aires, Argentina, C1405BOA
Teva Investigational Site 134
Buenos Aires, Argentina, C1425AHQ
Teva Investigational Site 235
Buenos Aires, Argentina, C1425CDC
Teva Investigational Site 462
Buenos Aires, Argentina
Teva Investigational Site 135
Cordoba, Argentina, 5004ALB
Teva Investigational Site 236
Cordoba, Argentina, X5009BIN
Teva Investigational Site 138
La Plata, Buenos Aires, Argentina, 01900
Teva Investigational Site 371
La Plata, Argentina, 41515
Teva Investigational Site 238
Rosario, Argentina, 2000
Australia
Teva Investigational Site 141
Brisbane, Australia, 4053
Teva Investigational Site 240
Malvern, Australia, 3144
Brazil
Teva Investigational Site 624
Rio de Janeiro, Brazil, 22270-060
Bulgaria
Teva Investigational Site 248
Bourgas, Bulgaria, 8000
Teva Investigational Site 146
Kardzhali, Bulgaria, 06600
Teva Investigational Site 148
Kazanlak, Bulgaria, 6100
Teva Investigational Site 853
Pazardjik, Bulgaria, 4400
Teva Investigational Site 852
Pleven, Bulgaria, 5800
Teva Investigational Site 249
Plovdiv, Bulgaria, 4000
Teva Investigational Site 145
Plovdiv, Bulgaria, 4002
Teva Investigational Site 370
Ruse, Bulgaria, 7003
Teva Investigational Site 147
Sofia, Bulgaria, 1377
Teva Investigational Site 854
Sofia, Bulgaria, 1431
Teva Investigational Site 855
Sofia, Bulgaria, 1431
Teva Investigational Site 247
Sofia, Bulgaria, 1632
Teva Investigational Site 851
Varna, Bulgaria, 9002
Teva Investigational Site 245
Varna, Bulgaria, 9010
Canada
Teva Investigational Site 198
Kelowna, Canada, V1Y 1Z9
Teva Investigational Site 296
Mississauga, Canada, L5M 4N4
Teva Investigational Site 196
Mississauga, Canada, L5M4N4
Teva Investigational Site 299
Penticton, Canada, V2A 4M4
Croatia
Teva Investigational Site 635
Rijeka, Croatia, 51000
Teva Investigational Site 633
Zagreb, Croatia, 10090
Teva Investigational Site 634
Zagreb, Croatia, 10090
France
Teva Investigational Site 286
Dole, France, 39100
Teva Investigational Site 153
Nimes, France, 30029
Germany
Teva Investigational Site 655
Achim, Germany, 28832
Teva Investigational Site 651
Dresden, Germany, 01307
Hungary
Teva Investigational Site 661
Budapest, Hungary, 1032
Teva Investigational Site 664
Budapest, Hungary, 1036
Teva Investigational Site 662
Budapest, Hungary, 1083
Teva Investigational Site 666
Nagykallo, Hungary, 4321
Italy
Teva Investigational Site 688
Catania, Italy, 95124
Teva Investigational Site 689
Firenze, Italy, 50134
Teva Investigational Site 687
Pisa, Italy, 56126
Teva Investigational Site 692
Rome, Italy, 00193
Poland
Teva Investigational Site 259
Bialystok, Poland, 15-879
Teva Investigational Site 258
Gdansk, Poland, 80-282
Teva Investigational Site 257
Gdansk, Poland, 80952
Teva Investigational Site 156
Kielce, Poland, 25-317
Teva Investigational Site 155
Krakow, Poland, 31-526
Teva Investigational Site 256
Leszno, Poland, 64-100
Teva Investigational Site 255
Skorzewo, Poland, 60-185
Teva Investigational Site 861
Szczecin, Poland, 71-460
Teva Investigational Site 157
Tuszyn, Poland, 95-080
Serbia
Teva Investigational Site 832
Belgrade, Serbia, 11 000
Teva Investigational Site 175
Belgrade, Serbia, 11000
Teva Investigational Site 177
Belgrade, Serbia, 11000
Teva Investigational Site 831
Belgrade, Serbia, 11000
Teva Investigational Site 833
Belgrade, Serbia, 11000
Teva Investigational Site 176
Kragujevac, Serbia, 34000
Teva Investigational Site 837
Nis, Serbia, 18000
Teva Investigational Site 834
Novi Knezevac, Serbia, 23330
Slovakia
Teva Investigational Site 699
Bratislava, Slovakia, 82007
Teva Investigational Site 697
Rimavska Sobota, Slovakia, 97901
Teva Investigational Site 696
Roznava, Slovakia, 04801
Teva Investigational Site 698
Trencin, Slovakia, 91101
South Africa
Teva Investigational Site 712
Cape Town, South Africa, 7530
Teva Investigational Site 709
Cape Town, South Africa, 7708
Teva Investigational Site 708
Centurion, South Africa, 0046
Teva Investigational Site 710
Johannesburg, South Africa, 2195
Teva Investigational Site 711
Paarl, South Africa, 7646
Teva Investigational Site 706
Pretoria, South Africa, 0181
Spain
Teva Investigational Site 336
Alcoy, Spain, 03804
Teva Investigational Site 434
Coslada (Madrid), Spain, 28822
Teva Investigational Site 430
Vitoria-Gasteiz, Spain, 01006
Teva Investigational Site 433
Vitoria, Spain, 01004
Ukraine
Teva Investigational Site 181
Dnipropetrovsk, Ukraine, 49027
Teva Investigational Site 872
Donetsk, Ukraine, 83099
Teva Investigational Site 282
Kharkiv, Ukraine, 61068
Teva Investigational Site 281
Kiev, Ukraine, 4080
Teva Investigational Site 180
Lugansk, Ukraine, 91045
Teva Investigational Site 873
Lviv, Ukraine, 79012
Teva Investigational Site 280
Odessa, Ukraine, 65014
Teva Investigational Site 875
Odessa, Ukraine, 65014
Teva Investigational Site 183
Poltava, Ukraine, 36006
Teva Investigational Site 871
S. Oleksandrivka, Ukraine, 65128
Teva Investigational Site 184
Simferopol, Ukraine, 95006
Teva Investigational Site 182
Vinnytsya, Ukraine, 21018
Sponsors and Collaborators
Cephalon
Investigators
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Study Director: Sponsor's Medical Expert Cephalon

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Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT01121536     History of Changes
Other Study ID Numbers: C10953/3074
2009-016648-38 ( EudraCT Number )
First Posted: May 12, 2010    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: September 21, 2018
Last Verified: August 2018
Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
Bipolar I Disorder
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action