Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00868699
First received: March 23, 2009
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression


Condition Intervention Phase
Bipolar Depression
Drug: lurasidone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

    Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.

    The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

    The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.



Secondary Outcome Measures:
  • Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

    Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.

    The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.


  • Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

    Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.

    The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

    The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.



Enrollment: 505
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lurasidone low arm Drug: lurasidone
lurasidone 20 mg/day for Days 1-7
Placebo Comparator: Placebo Drug: Placebo
Placebo Comparator
Experimental: lurasidone high arm Drug: lurasidone
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is diagnosed with bipolar I disorder, most resent episode depressed
  • Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

  • History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
  • Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
  • Imminent risk of suicide or injury to self, others, or property
  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: NCT00868699

  Hide Study Locations
Locations
United States, California
Synergy Escondido,710 East Grand Ave.
Escondido, California, United States, 92025
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
Garden Grove, California, United States, 92645
Excell Research, Inc,3998 Vista Way,Suite 100
Oceanside, California, United States, 92056
University of California at Irvine Medical Center
Orange, California, United States, 92868
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, United States, 90660
California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
San Diego, California, United States, 92102
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Florida Clinical Research Center, LLC,3914 State Road 64 East
Bradenton, Florida, United States, 34208
Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
Maitland, Florida, United States, 32751
Depression and Anxiety Disorders Research Institute
Tampa, Florida, United States, 33613
Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
West Palm Beach, Florida, United States, 33407
United States, Illinois
American Medical Research Inc.,1200 Harger Road Suite 415
Oak Brook, Illinois, United States, 60523
United States, Louisiana
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Sheppard Pratt Health System,6501 North Charles Street
Baltimore, Maryland, United States, 21285
United States, New Mexico
Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
Albuquerque, New Mexico, United States, 87109
United States, New York
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11516
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, North Carolina
Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
Raleigh, North Carolina, United States, 27609
United States, Ohio
Mood Disorders Program-UHCMC
Cleveland, Ohio, United States, 44106
MetroHealth System
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200
Austin, Texas, United States, 78756
Czech Republic
Medical Services Prague s.r.o.
Kolejni 429-5, Praha, Czech Republic
Psychiatricka ambulance
Brno - mesto, Czech Republic, 602 00
BIALBI s.r.o., Psychiatricke Oddeleni
Litomerice, Czech Republic
Clintrial, s.r.o.
Praha, Czech Republic, 10 100 00
France
Hopital Caremeau, Service de Psychiatrie A
Nimes Cedex, France, 30 30029
Zans Ritter, Marcel
Orvault, France, 44700
India
S V Medical College
Tirupati, Andh Prad, India, 517507
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
Vijaywada, Andh Prad, India, 520002
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, India, 380006
Mental Illness Treatment Rehabilitationi Foundation
Ahmedabad, Gujarat, India, 380013
Samvedna Hospitals
Ahmedabad, Gujarat, India, 380006
Spandana Nursing Home
Bangalore, Karna, India, 560010
Sujata Birla Hospital & Research Centre
Nashik, Mahara, India, 422101
R.K. Yadav Memorial Mental Health & De-Addiction Hospital
Jaipur, Rajasthan, India, 302021
Manobal Med. Research Centre
Lucknow, Uttar Prad, India, 226006
Romania
Spitalul Clinic de Urgenta Militar Central
Bucdresti, Romania, 010825
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
Bucuresti, Romania, 041914
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, Romania, 400012
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, Romania, 200620
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, Romania, 410154
Russian Federation
Bekhterev Scientific Research Psychoneurological Institute
St. Petersburg, Russian Federation, 193019
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
St. Petersburg, Russian Federation, 190121
Psychoneurology Dispensary #4
St. Petersburg, Russian Federation, 197110
South Africa
Cape Trial Centre
Cape Town, W. Cape, South Africa, 7530
Paarl Medical Centre
Paarl, W. Cape, South Africa, 7646
Clinika
Port Elizabeth, E. Cape, South Africa, 6000
Dey Clinic
Pretoria, Gauteng, South Africa, 0181
Vereeniging Medi-Clinic
Vereeniging, Free State, South Africa, 1941
Ukraine
Chair of Psychiatry and Medical Psychology
Donetsk, Ukraine, 83008
Reg. Psychiatric Hospital
Odessa, Ukraine
Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
Poltava, Ukraine, 36006
CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
Simferopol, Ukraine, 95006
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
Vinnitsia, Ukraine, 21018
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

Publications:
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00868699     History of Changes
Other Study ID Numbers: D1050236, EUDRACT No. 2008-007457-13
Study First Received: March 23, 2009
Results First Received: February 14, 2013
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: Ministry of Health

Keywords provided by Sunovion:
Bipolar I, Depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 20, 2014