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

NCT00868699 | Completed Phase 3 Results DMC

• 2 other identifiers: D1050236EUDRACT No. 2008-007457-13
• Study Type: interventional
• Target: 505
• Locations: 8 countries
• Sites: 55

Brief Summary

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

Conditions

Bipolar Depression

Keywords

Bipolar I, Depression

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)

  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.

  Baseline to Week 6

Secondary Outcomes (2)

• Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)

  Baseline to Week 6

• Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score

  Baseline to Week 6

Study Arms (3)

lurasidone low arm

EXPERIMENTAL

Drug: lurasidone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

lurasidone high arm

EXPERIMENTAL

Drug: lurasidone

Interventions

lurasidone DRUG

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

lurasidone high arm

Placebo DRUG

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (55)

Synergy Escondido,710 East Grand Ave.

Escondido, California, 92025, United States

Location

Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

Garden Grove, California, 92645, United States

Location

Excell Research, Inc,3998 Vista Way,Suite 100

Oceanside, California, 92056, United States

Location

University of California at Irvine Medical Center

Orange, California, 92868, United States

Location

California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

Pico Rivera, California, 90660, United States

Location

California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor

San Diego, California, 92102, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Florida Clinical Research Center, LLC,3914 State Road 64 East

Bradenton, Florida, 34208, United States

Location

Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230

Maitland, Florida, 32751, United States

Location

Depression and Anxiety Disorders Research Institute

Tampa, Florida, 33613, United States

Location

Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103

West Palm Beach, Florida, 33407, United States

Location

American Medical Research Inc.,1200 Harger Road Suite 415

Oak Brook, Illinois, 60523, United States

Location

Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

Lake Charles, Louisiana, 70601, United States

Location

Sheppard Pratt Health System,6501 North Charles Street

Baltimore, Maryland, 21285, United States

Location

Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209

Albuquerque, New Mexico, 87109, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125

Raleigh, North Carolina, 27609, United States

Location

Mood Disorders Program-UHCMC

Cleveland, Ohio, 44106, United States

Location

MetroHealth System

Cleveland, Ohio, 44122, United States

Location

CRI Worldwide, LLC

Philadelphia, Pennsylvania, 19139, United States

Location

FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200

Austin, Texas, 78756, United States

Location

Medical Services Prague s.r.o.

Kolejni 429-5, Prague, Czechia

Location

Psychiatricka ambulance

Brno - Mesto, 602 00, Czechia

Location

BIALBI s.r.o., Psychiatricke Oddeleni

Litoměřice, Czechia

Location

Clintrial, s.r.o.

Prague, 10 100 00, Czechia

Location

Hopital Caremeau, Service de Psychiatrie A

Nîmes, 30 30029, France

Location

Zans Ritter, Marcel

Orvault, 44700, France

Location

S V Medical College

Tirupati, Andh Prad, 517507, India

Location

Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

Vijaywada, Andh Prad, 520002, India

Location

Samvedna Hospitals

Ahmedabad, Gujarat, 380006, India

Location

Seth K M School of P G Medicine & Research

Ahmedabad, Gujarat, 380006, India

Location

Mental Illness Treatment Rehabilitationi Foundation

Ahmedabad, Gujarat, 380013, India

Location

Spandana Nursing Home

Bangalore, Karna, 560010, India

Location

Sujata Birla Hospital & Research Centre

Nashik, Mahara, 422101, India

Location

R.K. Yadav Memorial Mental Health & De-Addiction Hospital

Jaipur, Rajasthan, 302021, India

Location

Manobal Med. Research Centre

Lucknow, Uttar Prad, 226006, India

Location

Spitalul Clinic de Urgenta Militar Central

Bucdresti, 010825, Romania

Location

Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

Bucharest, 041914, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj

Cluj-Napoca, 400012, Romania

Location

Spitalul Clinic de Neuropsihiatrie Craiova

Craiova, 200620, Romania

Location

Spitalul Clinic de Neurologie si Psihiatrie Oradea

Oradea, 410154, Romania

Location

City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

Saint Petersburg, 190121, Russia

Location

Bekhterev Scientific Research Psychoneurological Institute

Saint Petersburg, 193019, Russia

Location

Psychoneurology Dispensary #4

Saint Petersburg, 197110, Russia

Location

Cape Trial Centre

Cape Town, W. Cape, 7530, South Africa

Location

Paarl Medical Centre

Paarl, W. Cape, 7646, South Africa

Location

Clinika

Port Elizabeth, E. Cape, 6000, South Africa

Location

Dey Clinic

Pretoria, Gauteng, 0181, South Africa

Location

Vereeniging Medi-Clinic

Vereeniging, Free State, 1941, South Africa

Location

Chair of Psychiatry and Medical Psychology

Donetsk, Donetsk Oblast, 83008, Ukraine

Location

Reg. Psychiatric Hospital

Odesa, Ukraine

Location

Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B

Poltava, 36006, Ukraine

Location

CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I

Simferopol, 95006, Ukraine

Location

Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

Vinnitsia, 21018, Ukraine

Location

Related Publications (8)

• Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.

  PMID: 24170180 RESULT

• Goldberg JF, Siu C, Tocco M, Pikalov A, Loebel A. The Effect of Lurasidone on Anxiety Symptoms in Patients With Bipolar Depression: A Post Hoc Analysis. J Clin Psychiatry. 2023 Jun 7;84(4):22m14732. doi: 10.4088/JCP.22m14732.

  PMID: 37339360 DERIVED

• Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.

  PMID: 30102967 DERIVED

• Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.

  PMID: 27529375 DERIVED

• Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.

  PMID: 27215976 DERIVED

• Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.

  PMID: 26730454 DERIVED

• Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.

  PMID: 26363720 DERIVED

• McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.

  PMID: 25844756 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director, CNS
• Organization: Sunovion

1-866-503-6351

Study Officials

• Medical Director, MD

  Sumitomo Pharma America, Inc.

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 25, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 17, 2014
• Results First Posted: July 2, 2013

Record last verified: 2014-03

Locations

FR (2); US (22); UA (5); IN (9); ZA (5); CZ (4); RU (3); RO (5)