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

NCT01305408 | Completed Phase 3 Results DMC

• 2 other identifiers: C10953/30732010-023623-26
• Study Type: interventional
• Target: 399
• Locations: 14 countries
• Sites: 130

Brief Summary

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.

Conditions

Depression

Keywords

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

  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

  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)

  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)

  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

  Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.

Drug: Placebo

Armodafinil 150 mg/day

EXPERIMENTAL

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

Interventions

Armodafinil DRUG

Armodafinil tablets, taken orally, once daily in the morning

Also known as: Nuvigil, CEP-10953

Armodafinil 150 mg/day

Placebo DRUG

Matching placebo tablets, taken orally, once daily in the morning

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.
• The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
• The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
• 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.
• The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (130)

Teva Investigational Site 225

Birmingham, Alabama, United States

Location

Teva Investigational Site 295

Sherman Oaks, California, United States

Location

Teva Investigational Site 122

Temecula, California, United States

Location

Teva Investigational Site 606

Jacksonville Beach, Florida, United States

Location

Teva Investigational Site 127

Lauderhill, Florida, United States

Location

Teva Investigational Site 608

Tampa, Florida, United States

Location

Teva Investigational Site 116

Atlanta, Georgia, United States

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Teva Investigational Site 205

Atlanta, Georgia, United States

Location

Teva Investigational Site 195

Park Ridge, Illinois, United States

Location

Teva Investigational Site 611

Indianapolis, Indiana, United States

Location

Teva Investigational Site 600

Lafayette, Indiana, United States

Location

Teva Investigational Site 603

Watertown, Massachusetts, United States

Location

Teva Investigational Site 207

Brooklyn, New York, United States

Location

Teva Investigational Site 202

New York, New York, United States

Location

Teva Investigational Site 110

Staten Island, New York, United States

Location

Teva Investigational Site 411

Staten Island, New York, United States

Location

Teva Investigational Site 614

Wilmington, North Carolina, United States

Location

Teva Investigational Site 610

Cincinnati, Ohio, United States

Location

Teva Investigational Site 615

Toledo, Ohio, United States

Location

Teva Investigational Site 401

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 609

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 616

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 406

Allentown, Pennsylvania, United States

Location

Teva Investigational Site 403

DeSoto, Texas, United States

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Teva Investigational Site 612

Friendswood, Texas, United States

Location

Teva Investigational Site 408

Salt Lake City, Utah, United States

Location

Teva Investigational Site 613

Kirkland, Washington, United States

Location

Teva Investigational Site 605

Spokane, Washington, United States

Location

Teva Investigational Site 134

Buenos Aires, Argentina

Location

Teva Investigational Site 136

Buenos Aires, Argentina

Location

Teva Investigational Site 881

Buenos Aires, Argentina

Location

Teva Investigational Site 884

Buenos Aires, Argentina

Location

Teva Investigational Site 888

Buenos Aires, Argentina

Location

Teva Investigational Site 236

Córdoba, Argentina

Location

Teva Investigational Site 135

Córdoba Capital, Argentina

Location

Teva Investigational Site 371

La Plata, Argentina

Location

Teva Investigational Site 886

La Plata, Argentina

Location

Teva Investigational Site 138

La Plata, Buenos Aires, Argentina

Location

Teva Investigational Site 882

Mendoza, Argentina

Location

Teva Investigational Site 883

Mendoza, Argentina

Location

Teva Investigational Site 885

Mendoza, Argentina

Location

Teva Investigational Site 887

Mendoza, Argentina

Location

Teva Investigational Site 238

Rosario, Argentina

Location

Teva Investigational Site 623

Belo Horizonte, Brazil

Location

Teva Investigational Site 626

Curitiba-Parana, Brazil

Location

Teva Investigational Site 621

Distrito de Rubiao Junior, Brazil

Location

Teva Investigational Site 627

Itapira -Sao Paulo, Brazil

Location

Teva Investigational Site 624

Rio de Janeiro, Brazil

Location

Teva Investigational Site 622

Salvador, Brazil

Location

Teva Investigational Site 628

São Paulo, Brazil

Location

Teva Investigational Site 248

Burgas, Bulgaria

Location

Teva Investigational Site 146

Kardzhali, Bulgaria

Location

Teva Investigational Site 148

Kazanlak, Bulgaria

Location

Teva Investigational Site 853

Pazardzhik, Bulgaria

Location

Teva Investigational Site 852

Pleven, Bulgaria

Location

Teva Investigational Site 145

Plovdiv, Bulgaria

Location

Teva Investigational Site 370

Rousse, Bulgaria

Location

Teva Investigational Site 147

Sofia, Bulgaria

Location

Teva Investigational Site 149

Sofia, Bulgaria

Location

Teva Investigational Site 244

Sofia, Bulgaria

Location

Teva Investigational Site 247

Sofia, Bulgaria

Location

Teva Investigational Site 854

Sofia, Bulgaria

Location

Teva Investigational Site 855

Sofia, Bulgaria

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Teva Investigational Site 245

Varna, Bulgaria

Location

Teva Investigational Site 851

Varna, Bulgaria

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Teva Investigational Site 856

Varna, Bulgaria

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Teva Investigational Site 635

Rijeka, Croatia

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Teva Investigational Site 631

Split, Croatia

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Teva Investigational Site 632

Zagreb, Croatia

Location

Teva Investigational Site 633

Zagreb, Croatia

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Teva Investigational Site 634

Zagreb, Croatia

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Teva Investigational Site 716

Helsinki, Finland

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Teva Investigational Site 717

Helsinki, Finland

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Teva Investigational Site 719

Kangasala, Finland

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Teva Investigational Site 718

Turku, Finland

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Teva Investigational Site 655

Achim, Germany

Location

Teva Investigational Site 656

Berlin, Germany

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Teva Investigational Site 653

Cologne, Germany

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Teva Investigational Site 651

Dresden, Germany

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Teva Investigational Site 654

Freiburg im Breisgau, Germany

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Teva Investigational Site 652

Mittweida, Germany

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Teva Investigational Site 661

Budapest, Hungary

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Teva Investigational Site 662

Budapest, Hungary

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Teva Investigational Site 664

Budapest, Hungary

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Teva Investigational Site 665

Győr, Hungary

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Teva Investigational Site 666

Nagykálló, Hungary

Location

Teva Investigational Site 688

Catania, Italy

Location

Teva Investigational Site 689

Florence, Italy

Location

Teva Investigational Site 686

Genova, Italy

Location

Teva Investigational Site 691

Lido Di Camaiore(LU), Italy

Location

Teva Investigational Site 690

Naples, Italy

Location

Teva Investigational Site 687

Pisa, Italy

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Teva Investigational Site 693

Pisa, Italy

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Teva Investigational Site 692

Roma, Italy

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Teva Investigational Site 259

Bialystok, Poland

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Teva Investigational Site 257

Gdansk, Poland

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Teva Investigational Site 258

Gdynia, Poland

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Teva Investigational Site 155

Krakow, Poland

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Teva Investigational Site 255

Skorzewo, Poland

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Teva Investigational Site 861

Szczecin, Poland

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Teva Investigational Site 157

Tuszyn, Poland

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Teva Investigational Site 177

Belgrade, Serbia

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Teva Investigational Site 831

Belgrade, Serbia

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Teva Investigational Site 832

Belgrade, Serbia

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Teva Investigational Site 835

Belgrade, Serbia

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Teva Investigational Site 176

Kragujevac, Serbia

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Teva Investigational Site 837

Niš, Serbia

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Teva Investigational Site 834

Novi Kneževac, Serbia

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Teva Investigational Site 700

Bojnice, Slovakia

Location

Teva Investigational Site 699

Bratislava, Slovakia

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Teva Investigational Site 697

Rimavská Sobota, Slovakia

Location

Teva Investigational Site 696

Rožňava, Slovakia

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Teva Investigational Site 698

Trenčín, Slovakia

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Teva Investigational Site 707

Cape Town, South Africa

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Teva Investigational Site 709

Cape Town, South Africa

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Teva Investigational Site 712

Cape Town, South Africa

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Teva Investigational Site 708

Centurion, South Africa

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Teva Investigational Site 710

Johannesburg, South Africa

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Teva Investigational Site 711

Paarl, South Africa

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Teva Investigational Site 706

Pretoria, South Africa

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Teva Investigational Site 181

Dnipropetrovsk, Ukraine

Location

Teva Investigational Site 872

Donetsk, Ukraine

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Teva Investigational Site 282

Kharkiv, Ukraine

Location

Teva Investigational Site 281

Kiev, Ukraine

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Teva Investigational Site 180

Luhansk, Ukraine

Location

Teva Investigational Site 873

Lviv, Ukraine

Location

Teva Investigational Site 875

Odesa, Ukraine

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Teva Investigational Site 183

Poltava, Ukraine

Location

Teva Investigational Site 871

S. Oleksandrivka, Ukraine

Location

Teva Investigational Site 182

Vinnytsia, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 26330288 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Sponsor's Medical Expert

  Cephalon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 26, 2016
• Results First Posted: January 26, 2015

Record last verified: 2016-04

Locations

PL (7); FI (4); SE (7); US (28); IT (8); SL (5); ZA (7); HU (5); UA (10); AR (15); BR (7); BU (16); CR (5); DE (6)