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
NCT ID: NCT01305408
Last Updated: 2016-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
399 participants
INTERVENTIONAL
2011-03-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
Placebo
Matching placebo tablets, taken orally, once daily in the morning
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.
Armodafinil
Armodafinil tablets, taken orally, once daily in the morning
Interventions
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Armodafinil
Armodafinil tablets, taken orally, once daily in the morning
Placebo
Matching placebo tablets, taken orally, once daily in the morning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Principal Investigators
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Sponsor's Medical Expert
Role: STUDY_DIRECTOR
Cephalon
Locations
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Teva Investigational Site 225
Birmingham, Alabama, United States
Teva Investigational Site 295
Sherman Oaks, California, United States
Teva Investigational Site 122
Temecula, California, United States
Teva Investigational Site 606
Jacksonville Beach, Florida, United States
Teva Investigational Site 127
Lauderhill, Florida, United States
Teva Investigational Site 608
Tampa, Florida, United States
Teva Investigational Site 116
Atlanta, Georgia, United States
Teva Investigational Site 205
Atlanta, Georgia, United States
Teva Investigational Site 195
Park Ridge, Illinois, United States
Teva Investigational Site 611
Indianapolis, Indiana, United States
Teva Investigational Site 600
Lafayette, Indiana, United States
Teva Investigational Site 603
Watertown, Massachusetts, United States
Teva Investigational Site 207
Brooklyn, New York, United States
Teva Investigational Site 202
New York, New York, United States
Teva Investigational Site 110
Staten Island, New York, United States
Teva Investigational Site 411
Staten Island, New York, United States
Teva Investigational Site 614
Wilmington, North Carolina, United States
Teva Investigational Site 610
Cincinnati, Ohio, United States
Teva Investigational Site 615
Toledo, Ohio, United States
Teva Investigational Site 401
Oklahoma City, Oklahoma, United States
Teva Investigational Site 609
Oklahoma City, Oklahoma, United States
Teva Investigational Site 616
Oklahoma City, Oklahoma, United States
Teva Investigational Site 406
Allentown, Pennsylvania, United States
Teva Investigational Site 403
DeSoto, Texas, United States
Teva Investigational Site 612
Friendswood, Texas, United States
Teva Investigational Site 408
Salt Lake City, Utah, United States
Teva Investigational Site 613
Kirkland, Washington, United States
Teva Investigational Site 605
Spokane, Washington, United States
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
Buenos Aires, , Argentina
Teva Investigational Site 236
Córdoba, , Argentina
Teva Investigational Site 135
Córdoba Capital, , Argentina
Teva Investigational Site 371
La Plata, , Argentina
Teva Investigational Site 886
La Plata, , Argentina
Teva Investigational Site 138
La Plata, Buenos Aires, , Argentina
Teva Investigational Site 882
Mendoza, , Argentina
Teva Investigational Site 883
Mendoza, , Argentina
Teva Investigational Site 885
Mendoza, , Argentina
Teva Investigational Site 887
Mendoza, , Argentina
Teva Investigational Site 238
Rosario, , Argentina
Teva Investigational Site 623
Belo Horizonte, , Brazil
Teva Investigational Site 626
Curitiba-Parana, , Brazil
Teva Investigational Site 621
Distrito de Rubiao Junior, , Brazil
Teva Investigational Site 627
Itapira -Sao Paulo, , Brazil
Teva Investigational Site 624
Rio de Janeiro, , Brazil
Teva Investigational Site 622
Salvador, , Brazil
Teva Investigational Site 628
São Paulo, , Brazil
Teva Investigational Site 248
Burgas, , Bulgaria
Teva Investigational Site 146
Kardzhali, , Bulgaria
Teva Investigational Site 148
Kazanlak, , Bulgaria
Teva Investigational Site 853
Pazardzhik, , Bulgaria
Teva Investigational Site 852
Pleven, , Bulgaria
Teva Investigational Site 145
Plovdiv, , Bulgaria
Teva Investigational Site 370
Rousse, , 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
Sofia, , Bulgaria
Teva Investigational Site 245
Varna, , Bulgaria
Teva Investigational Site 851
Varna, , Bulgaria
Teva Investigational Site 856
Varna, , Bulgaria
Teva Investigational Site 635
Rijeka, , Croatia
Teva Investigational Site 631
Split, , Croatia
Teva Investigational Site 632
Zagreb, , Croatia
Teva Investigational Site 633
Zagreb, , Croatia
Teva Investigational Site 634
Zagreb, , Croatia
Teva Investigational Site 716
Helsinki, , Finland
Teva Investigational Site 717
Helsinki, , Finland
Teva Investigational Site 719
Kangasala, , Finland
Teva Investigational Site 718
Turku, , Finland
Teva Investigational Site 655
Achim, , Germany
Teva Investigational Site 656
Berlin, , Germany
Teva Investigational Site 653
Cologne, , Germany
Teva Investigational Site 651
Dresden, , Germany
Teva Investigational Site 654
Freiburg im Breisgau, , Germany
Teva Investigational Site 652
Mittweida, , Germany
Teva Investigational Site 661
Budapest, , Hungary
Teva Investigational Site 662
Budapest, , Hungary
Teva Investigational Site 664
Budapest, , Hungary
Teva Investigational Site 665
Győr, , Hungary
Teva Investigational Site 666
Nagykálló, , Hungary
Teva Investigational Site 688
Catania, , Italy
Teva Investigational Site 689
Florence, , Italy
Teva Investigational Site 686
Genova, , Italy
Teva Investigational Site 691
Lido Di Camaiore(LU), , Italy
Teva Investigational Site 690
Naples, , Italy
Teva Investigational Site 687
Pisa, , Italy
Teva Investigational Site 693
Pisa, , Italy
Teva Investigational Site 692
Roma, , Italy
Teva Investigational Site 259
Bialystok, , Poland
Teva Investigational Site 257
Gdansk, , Poland
Teva Investigational Site 258
Gdynia, , Poland
Teva Investigational Site 155
Krakow, , Poland
Teva Investigational Site 255
Skorzewo, , Poland
Teva Investigational Site 861
Szczecin, , Poland
Teva Investigational Site 157
Tuszyn, , Poland
Teva Investigational Site 177
Belgrade, , Serbia
Teva Investigational Site 831
Belgrade, , Serbia
Teva Investigational Site 832
Belgrade, , Serbia
Teva Investigational Site 835
Belgrade, , Serbia
Teva Investigational Site 176
Kragujevac, , Serbia
Teva Investigational Site 837
Niš, , Serbia
Teva Investigational Site 834
Novi Kneževac, , Serbia
Teva Investigational Site 700
Bojnice, , Slovakia
Teva Investigational Site 699
Bratislava, , Slovakia
Teva Investigational Site 697
Rimavská Sobota, , Slovakia
Teva Investigational Site 696
Rožňava, , Slovakia
Teva Investigational Site 698
Trenčín, , Slovakia
Teva Investigational Site 707
Cape Town, , South Africa
Teva Investigational Site 709
Cape Town, , South Africa
Teva Investigational Site 712
Cape Town, , South Africa
Teva Investigational Site 708
Centurion, , South Africa
Teva Investigational Site 710
Johannesburg, , South Africa
Teva Investigational Site 711
Paarl, , South Africa
Teva Investigational Site 706
Pretoria, , South Africa
Teva Investigational Site 181
Dnipropetrovsk, , Ukraine
Teva Investigational Site 872
Donetsk, , Ukraine
Teva Investigational Site 282
Kharkiv, , Ukraine
Teva Investigational Site 281
Kiev, , Ukraine
Teva Investigational Site 180
Luhansk, , Ukraine
Teva Investigational Site 873
Lviv, , Ukraine
Teva Investigational Site 875
Odesa, , Ukraine
Teva Investigational Site 183
Poltava, , Ukraine
Teva Investigational Site 871
S. Oleksandrivka, , Ukraine
Teva Investigational Site 182
Vinnytsia, , Ukraine
Countries
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References
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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.
Other Identifiers
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2010-023623-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C10953/3073
Identifier Type: -
Identifier Source: org_study_id
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