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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01305408
First received: February 25, 2011
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Armodafinil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: at all post-baseline visits up to Week 8 ] [ Designated as safety issue: No ]
    The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a paient's depressive symptoms. The scale uses the DSM-IV criteria to measure symptoms or severity. Following the administration of the IDS-C30 by a qualified rater at the study center, each patient will complete an interactive computerized interview on a dedicated study laptop computer.


Secondary Outcome Measures:
  • Clinical Global Impression of Severity (CGI-S) of depression rating [ Time Frame: at weeks 1, 2, 4, 6, 7,and 8, or last postbaseline observation ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning (GAF) Scale scores [ Time Frame: at weeks 4 and 8, or last postbaseline observation ] [ Designated as safety issue: No ]

Enrollment: 398
Study Start Date: March 2011
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Armodafinil Drug: Armodafinil
Armodafinil at 150 mg/day
Placebo Comparator: Placebo Drug: Placebo
Matching Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a diagnosis of bipolar I disorder according to 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305408

  Hide Study Locations
Locations
United States, Alabama
Teva Investigational Site 225
Birmingham, Alabama, United States
United States, California
Teva Investigational Site 295
Sherman Oaks, California, United States
Teva Investigational Site 122
Temecula, California, United States
United States, Florida
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
United States, Georgia
Teva Investigational Site 116
Atlanta, Georgia, United States
Teva Investigational Site 205
Atlanta, Georgia, United States
United States, Illinois
Teva Investigational Site 195
Park Ridge, Illinois, United States
United States, Indiana
Teva Investigational Site 611
Indianapolis, Indiana, United States
Teva Investigational Site 600
Lafayette, Indiana, United States
United States, Massachusetts
Teva Investigational Site 603
Watertown, Massachusetts, United States
United States, New York
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
United States, North Carolina
Teva Investigational Site 614
Wilmington, North Carolina, United States
United States, Ohio
Teva Investigational Site 610
Cincinnati, Ohio, United States
Teva Investigational Site 615
Toledo, Ohio, United States
United States, Oklahoma
Teva Investigational Site 616
Oklahoma City, Oklahoma, United States
Teva Investigational Site 401
Oklahoma City, Oklahoma, United States
Teva Investigational Site 609
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Teva Investigational Site 406
Allentown, Pennsylvania, United States
United States, Texas
Teva Investigational Site 403
Desoto, Texas, United States
Teva Investigational Site 612
Friendswood, Texas, United States
United States, Utah
Teva Investigational Site 408
Salt Lake City, Utah, United States
United States, Washington
Teva Investigational Site 613
Kirkland, Washington, United States
Teva Investigational Site 605
Spokane, Washington, United States
Argentina
Teva Investigational Site 136
Buenos Aires, Argentina
Teva Investigational Site 134
Buenos Aires, Argentina
Teva Investigational Site 881
Buenos Aires, Argentina
Teva Investigational Site 888
Buenos Aires, Argentina
Teva Investigational Site 884
Buenos Aires, Argentina
Teva Investigational Site 236
Córdoba, Argentina
Teva Investigational Site 135
Córdoba Capital, Argentina
Teva Investigational Site 886
La Plata, Argentina
Teva Investigational Site 371
La Plata, Argentina
Teva Investigational Site 138
La Plata, Buenos Aires, Argentina
Teva Investigational Site 883
Mendoza, Argentina
Teva Investigational Site 882
Mendoza, Argentina
Teva Investigational Site 887
Mendoza, Argentina
Teva Investigational Site 885
Mendoza, Argentina
Teva Investigational Site 238
Rosario, Argentina
Brazil
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
Sao Paolo, Brazil
Bulgaria
Teva Investigational Site 248
Bourgas, Bulgaria
Teva Investigational Site 146
Kardzhali, Bulgaria
Teva Investigational Site 148
Kazanlak, Bulgaria
Teva Investigational Site 853
Pazardjik, Bulgaria
Teva Investigational Site 852
Pleven, Bulgaria
Teva Investigational Site 145
Plovdiv, Bulgaria
Teva Investigational Site 370
Ruse, Bulgaria
Teva Investigational Site 854
Sofia, Bulgaria
Teva Investigational Site 247
Sofia, Bulgaria
Teva Investigational Site 147
Sofia, Bulgaria
Teva Investigational Site 149
Sofia, Bulgaria
Teva Investigational Site 244
Sofia, Bulgaria
Teva Investigational Site 855
Sofia, Bulgaria
Teva Investigational Site 245
Varna, Bulgaria
Teva Investigational Site 856
Varna, Bulgaria
Teva Investigational Site 851
Varna, Bulgaria
Croatia
Teva Investigational Site 635
Rijeka, Croatia
Teva Investigational Site 631
Split, Croatia
Teva Investigational Site 633
Zagreb, Croatia
Teva Investigational Site 634
Zagreb, Croatia
Teva Investigational Site 632
Zagreb, Croatia
Finland
Teva Investigational Site 717
Helsinki, Finland
Teva Investigational Site 716
Helsinki, Finland
Teva Investigational Site 719
Kangasala, Finland
Teva Investigational Site 718
Turku, Finland
Germany
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, Germany
Teva Investigational Site 652
Mittweida, Germany
Hungary
Teva Investigational Site 661
Budapest, Hungary
Teva Investigational Site 664
Budapest, Hungary
Teva Investigational Site 662
Budapest, Hungary
Teva Investigational Site 665
Gyor, Hungary
Teva Investigational Site 666
Nagykallo, Hungary
Italy
Teva Investigational Site 688
Catania, Italy
Teva Investigational Site 689
Firenze, 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 693
Pisa, Italy
Teva Investigational Site 687
Pisa, Italy
Teva Investigational Site 692
Roma, Italy
Poland
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
Serbia
Teva Investigational Site 177
Belgrade, Serbia
Teva Investigational Site 835
Belgrade, Serbia
Teva Investigational Site 831
Belgrade, Serbia
Teva Investigational Site 832
Belgrade, Serbia
Teva Investigational Site 176
Kragujevac, Serbia
Teva Investigational Site 837
Nis, Serbia
Teva Investigational Site 834
Novi Knezevac, Serbia
Slovakia
Teva Investigational Site 700
Bojnice, Slovakia
Teva Investigational Site 699
Bratislava, Slovakia
Teva Investigational Site 697
Rimavska Sobota, Slovakia
Teva Investigational Site 696
Roznava, Slovakia
Teva Investigational Site 698
Trencin, Slovakia
South Africa
Teva Investigational Site 712
Cape Town, South Africa
Teva Investigational Site 709
Cape Town, South Africa
Teva Investigational Site 707
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
Ukraine
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
Lugansk, Ukraine
Teva Investigational Site 873
Lviv, Ukraine
Teva Investigational Site 875
Odessa, Ukraine
Teva Investigational Site 183
Poltava, Ukraine
Teva Investigational Site 871
s. Oleksandrivka, Ukraine
Teva Investigational Site 182
Vinnytsya, Ukraine
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01305408     History of Changes
Other Study ID Numbers: C10953/3073
Study First Received: February 25, 2011
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014