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

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

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Placebo; Drug: Armodafinil

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Teva Investigational Site 134
  • Buenos Aires, Argentina
    • Teva Investigational Site 136
  • Buenos Aires, Argentina
    • Teva Investigational Site 881
  • Buenos Aires, Argentina
    • Teva Investigational Site 884
  • Buenos Aires, Argentina
    • Teva Investigational Site 888
  • Córdoba, Argentina
    • Teva Investigational Site 236
  • Córdoba Capital, Argentina
    • Teva Investigational Site 135
  • La Plata, Argentina
    • Teva Investigational Site 371
  • La Plata, Argentina
    • Teva Investigational Site 886
  • La Plata, Buenos Aires, Argentina
    • Teva Investigational Site 138
  • Mendoza, Argentina
    • Teva Investigational Site 882
  • Mendoza, Argentina
    • Teva Investigational Site 883
  • Mendoza, Argentina
    • Teva Investigational Site 885
  • Mendoza, Argentina
    • Teva Investigational Site 887
  • Rosario, Argentina
    • Teva Investigational Site 238
• Brazil
  • Belo Horizonte, Brazil
    • Teva Investigational Site 623
  • Curitiba-Parana, Brazil
    • Teva Investigational Site 626
  • Distrito de Rubiao Junior, Brazil
    • Teva Investigational Site 621
  • Itapira -Sao Paulo, Brazil
    • Teva Investigational Site 627
  • Rio de Janeiro, Brazil
    • Teva Investigational Site 624
  • Salvador, Brazil
    • Teva Investigational Site 622
  • Sao Paolo, Brazil
    • Teva Investigational Site 628
• Bulgaria
  • Bourgas, Bulgaria
    • Teva Investigational Site 248
  • Kardzhali, Bulgaria
    • Teva Investigational Site 146
  • Kazanlak, Bulgaria
    • Teva Investigational Site 148
  • Pazardjik, Bulgaria
    • Teva Investigational Site 853
  • Pleven, Bulgaria
    • Teva Investigational Site 852
  • Plovdiv, Bulgaria
    • Teva Investigational Site 145
  • Ruse, Bulgaria
    • Teva Investigational Site 370
  • Sofia, Bulgaria
    • Teva Investigational Site 147
  • Sofia, Bulgaria
    • Teva Investigational Site 149
  • Sofia, Bulgaria
    • Teva Investigational Site 244
  • Sofia, Bulgaria
    • Teva Investigational Site 247
  • Sofia, Bulgaria
    • Teva Investigational Site 854
  • Sofia, Bulgaria
    • Teva Investigational Site 855
  • Varna, Bulgaria
    • Teva Investigational Site 245
  • Varna, Bulgaria
    • Teva Investigational Site 851
  • Varna, Bulgaria
    • Teva Investigational Site 856
• Croatia
  • Rijeka, Croatia
    • Teva Investigational Site 635
  • Split, Croatia
    • Teva Investigational Site 631
  • Zagreb, Croatia
    • Teva Investigational Site 632
  • Zagreb, Croatia
    • Teva Investigational Site 633
  • Zagreb, Croatia
    • Teva Investigational Site 634
• Finland
  • Helsinki, Finland
    • Teva Investigational Site 716
  • Helsinki, Finland
    • Teva Investigational Site 717
  • Kangasala, Finland
    • Teva Investigational Site 719
  • Turku, Finland
    • Teva Investigational Site 718
• Germany
  • Achim, Germany
    • Teva Investigational Site 655
  • Berlin, Germany
    • Teva Investigational Site 656
  • Cologne, Germany
    • Teva Investigational Site 653
  • Dresden, Germany
    • Teva Investigational Site 651
  • Freiburg, Germany
    • Teva Investigational Site 654
  • Mittweida, Germany
    • Teva Investigational Site 652
• Hungary
  • Budapest, Hungary
    • Teva Investigational Site 661
  • Budapest, Hungary
    • Teva Investigational Site 662
  • Budapest, Hungary
    • Teva Investigational Site 664
  • Gyor, Hungary
    • Teva Investigational Site 665
  • Nagykallo, Hungary
    • Teva Investigational Site 666
• Italy
  • Catania, Italy
    • Teva Investigational Site 688
  • Firenze, Italy
    • Teva Investigational Site 689
  • Genova, Italy
    • Teva Investigational Site 686
  • Lido di Camaiore(LU), Italy
    • Teva Investigational Site 691
  • Naples, Italy
    • Teva Investigational Site 690
  • Pisa, Italy
    • Teva Investigational Site 687
  • Pisa, Italy
    • Teva Investigational Site 693
  • Roma, Italy
    • Teva Investigational Site 692
• Poland
  • Bialystok, Poland
    • Teva Investigational Site 259
  • Gdansk, Poland
    • Teva Investigational Site 257
  • Gdynia, Poland
    • Teva Investigational Site 258
  • Krakow, Poland
    • Teva Investigational Site 155
  • Skorzewo, Poland
    • Teva Investigational Site 255
  • Szczecin, Poland
    • Teva Investigational Site 861
  • Tuszyn, Poland
    • Teva Investigational Site 157
• Serbia
  • Belgrade, Serbia
    • Teva Investigational Site 177
  • Belgrade, Serbia
    • Teva Investigational Site 831
  • Belgrade, Serbia
    • Teva Investigational Site 832
  • Belgrade, Serbia
    • Teva Investigational Site 835
  • Kragujevac, Serbia
    • Teva Investigational Site 176
  • Nis, Serbia
    • Teva Investigational Site 837
  • Novi Knezevac, Serbia
    • Teva Investigational Site 834
• Slovakia
  • Bojnice, Slovakia
    • Teva Investigational Site 700
  • Bratislava, Slovakia
    • Teva Investigational Site 699
  • Rimavska Sobota, Slovakia
    • Teva Investigational Site 697
  • Roznava, Slovakia
    • Teva Investigational Site 696
  • Trencin, Slovakia
    • Teva Investigational Site 698
• South Africa
  • Cape Town, South Africa
    • Teva Investigational Site 707
  • Cape Town, South Africa
    • Teva Investigational Site 709
  • Cape Town, South Africa
    • Teva Investigational Site 712
  • Centurion, South Africa
    • Teva Investigational Site 708
  • Johannesburg, South Africa
    • Teva Investigational Site 710
  • Paarl, South Africa
    • Teva Investigational Site 711
  • Pretoria, South Africa
    • Teva Investigational Site 706
• Ukraine
  • Dnipropetrovsk, Ukraine
    • Teva Investigational Site 181
  • Donetsk, Ukraine
    • Teva Investigational Site 872
  • Kharkiv, Ukraine
    • Teva Investigational Site 282
  • Kiev, Ukraine
    • Teva Investigational Site 281
  • Lugansk, Ukraine
    • Teva Investigational Site 180
  • Lviv, Ukraine
    • Teva Investigational Site 873
  • Odessa, Ukraine
    • Teva Investigational Site 875
  • Poltava, Ukraine
    • Teva Investigational Site 183
  • Vinnytsya, Ukraine
    • Teva Investigational Site 182
  • s. Oleksandrivka, Ukraine
    • Teva Investigational Site 871
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Teva Investigational Site 225
  • California
    • Sherman Oaks, California, United States
      • Teva Investigational Site 295
    • Temecula, California, United States
      • Teva Investigational Site 122
  • Florida
    • Jacksonville Beach, Florida, United States
      • Teva Investigational Site 606
    • Lauderhill, Florida, United States
      • Teva Investigational Site 127
    • Tampa, Florida, United States
      • Teva Investigational Site 608
  • Georgia
    • Atlanta, Georgia, United States
      • Teva Investigational Site 116
    • Atlanta, Georgia, United States
      • Teva Investigational Site 205
  • Illinois
    • Park Ridge, Illinois, United States
      • Teva Investigational Site 195
  • Indiana
    • Indianapolis, Indiana, United States
      • Teva Investigational Site 611
    • Lafayette, Indiana, United States
      • Teva Investigational Site 600
  • Massachusetts
    • Watertown, Massachusetts, United States
      • Teva Investigational Site 603
  • New York
    • Brooklyn, New York, United States
      • Teva Investigational Site 207
    • New York, New York, United States
      • Teva Investigational Site 202
    • Staten Island, New York, United States
      • Teva Investigational Site 110
    • Staten Island, New York, United States
      • Teva Investigational Site 411
  • North Carolina
    • Wilmington, North Carolina, United States
      • Teva Investigational Site 614
  • Ohio
    • Cincinnati, Ohio, United States
      • Teva Investigational Site 610
    • Toledo, Ohio, United States
      • Teva Investigational Site 615
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 401
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 609
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 616
  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • Teva Investigational Site 406
  • Texas
    • Desoto, Texas, United States
      • Teva Investigational Site 403
    • Friendswood, Texas, United States
      • Teva Investigational Site 612
  • Utah
    • Salt Lake City, Utah, United States
      • Teva Investigational Site 408
  • Washington
    • Kirkland, Washington, United States
      • Teva Investigational Site 613
    • Spokane, Washington, United States
      • Teva Investigational Site 605

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
• Documentation that the patient has had at least 1 previous manic or mixed episode.
• The patient has had no more than 6 mood episodes in the last year.
• The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.

• The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

  1. The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
  2. The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
  3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
  4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
  5. The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
  6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

Exclusion Criteria:

• The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
• The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
• 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 has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.	Drug: Placebo; Matching placebo tablets, taken orally, once daily in the morning
Experimental: Armodafinil 150 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. Treatment was administered for a total of 8 weeks.	Drug: Armodafinil; Armodafinil tablets, taken orally, once daily in the morning; Other Names: Nuvigil; CEP-10953

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 8 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.	Day 0 (baseline), Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score	A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the 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.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score	A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. 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.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Different Treatment Weeks 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.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Different Treatment Weeks 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.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Different Treatment Weeks 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.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Weeks 4, 8 and 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.	Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)
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.	Day 1 to Week 9
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.	Day 0 (baseline), last postbaseline observation (up to 8 weeks)
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.	Day 0 (baseline), last postbaseline observation (up to 8 weeks)
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.	Day 0 (baseline), last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question	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 C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Collaborators and Investigators

• Sponsor: Cephalon

Publications and helpful links

General Publications

• Frye MA, Amchin J, Bauer M, Adler C, Yang R, Ketter TA. Randomized, placebo-controlled, adjunctive study of armodafinil for bipolar I depression: implications of novel drug design and heterogeneity of concurrent bipolar maintenance treatments. Int J Bipolar Disord. 2015 Dec;3(1):34. doi: 10.1186/s40345-015-0034-0. Epub 2015 Sep 2.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): May 26, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Bipolar I Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: C10953/3073; 2010-023623-26 (EudraCT Number)