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

NCT00868452 | Completed Phase 3 Results DMC

• 2 other identifiers: D1050235EUDRACT No. 2008-007482-23
• Study Type: interventional
• Target: 348
• Locations: 10 countries
• Sites: 71

Brief Summary

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

Conditions

Bipolar Depression

Keywords

Bipolar I; Latuda; Lurasidone

Outcome Measures

Primary Outcomes (1)

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

  MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

  Baseline, 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 Week 6

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

  Baselin Week 6

Study Arms (2)

Lurasidone

EXPERIMENTAL

Drug: lurasidone + (lithium or divalproex)

Placebo

PLACEBO COMPARATOR

Drug: Placebo + (lithium or divalproex)

Interventions

lurasidone + (lithium or divalproex) DRUG

lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.

Lurasidone

Placebo + (lithium or divalproex) DRUG

20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7

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
• Subject must be taking lithium or divalproex at least 28 days prior to screening

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 (71)

Woodland International Research Inc.

Little Rock, Arkansas, 72211, United States

Location

South Coast Clinical Trials, Inc.

Anaheim, California, 92804, United States

Location

Catalina Research Institute

Chino, California, 91710, United States

Location

Synergy Escondido

Escondido, California, 92025, United States

Location

Collaborative Neuroscience Network Inc.,12772 Valley View Street

Garden Grove, California, 92645, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California at Irvine Medical Center

Orange, California, 92868, United States

Location

CNRI - Los Angeles LLC,8309 Telegraph Road

Pico Rivera, California, 90660, United States

Location

CNRI - San Diego, LLC

San Diego, California, 92102, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Depression and Anxiety Disorders Research Institue

Tampa, Florida, 33613, United States

Location

American Medical Research Inc.,1200 Harger Road Suite 415

Oak Brook, Illinois, 60523, United States

Location

American Medical Research, Inc., 1200 Harger Road Suite 415

Oak Brook, Illinois, 60523, United States

Location

J. Gary Booker, MD

Shreveport, Louisiana, 71104, United States

Location

Sheppard Pratt Health System,6501 North Charles Street

Baltimore, Maryland, 21285, United States

Location

Capital Clinical Research,5515 Security Lane, Suite 525

Rockville, Maryland, 20852, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209

Albuquerque, New Mexico, 87109, United States

Location

Lake Charles Clinical Trials LLC,700 Spring Forest Road

Raleigh, North Carolina, 27609, United States

Location

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

Raleigh, North Carolina, 27609, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Mood Disorders Program-UHCMC

Cleveland, Ohio, 44106, United States

Location

MetroHealth System

Cleveland, Ohio, 44122, United States

Location

Midwest Clinical research Center, One Elizabeth Place, Suite G-3

Dayton, Ohio, 45408, 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

Psychiatricka ambulance

Brno - Mesto, 602 00, Czechia

Location

BIALBI s.r.o. Psychiatricke oddeleni

Litoměřice, 412 01, Czechia

Location

Clintrial, s.r.o.

Prague, 10 100 00, Czechia

Location

Medical Services Prague s.r.o.

Prague, 6 160 00, Czechia

Location

Psychiatricka ambulance Prosek

Prague, 9 190 00, Czechia

Location

Hopital Caremeau, Service de Psychiatrie A

Nîmes, 30 30029, France

Location

Zans Ritter, Marcel

Orvault, 44700, France

Location

Jana Thomsen

Berlin BE, 10245, Germany

Location

SV 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

Sheth Vadilal Sarabhai General Hospital

Ahmedabad, Gujarat, 380006, India

Location

Mental Illness Treatment Rehabilitation Foundation (MITR)

Ahmedabad, Gujarat, 380013, India

Location

Shree Hatkesh Health Foundation

Jūnāgadh, Gujarat, 362001, India

Location

Spandana Nursing Home

Bangalore, Karna, 560010, India

Location

Sujata Birla Hospital & Research Centre

Nashik, Mahara, 422101, India

Location

Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

Delhi, National Capital Territory of Delhi, 110092, 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

ZOZ Poradnia Zdrowia Psychicznego

Chełmno, 86-200, Poland

Location

Praktyka Lekarska Sensorium S.M.O.

Skorzewo, 60-185, Poland

Location

Wojewodzki Szpital Brodnowski SP ZOZ

Warsaw, 03-242, Poland

Location

Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie

Bucharest, 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

Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric

Piteşti, 110069, Romania

Location

Russian State Medical University

Moscow, 117997, Russia

Location

Moscow Medical Academy named I.M. Sechenov

Moscow, 119435, Russia

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

LLC International Medical Centre "SOGAZ"

Saint Petersburg, 198035, 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

Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy

Donetsk, 83008, Ukraine

Location

Odesa Regional Psychoneurological Dispensary

Odesa, 65014, Ukraine

Location

Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM

Poltava, 36006, Ukraine

Location

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

Simferopol, 95006, Ukraine

Location

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

Vinnitsia, 21005, Ukraine

Location

Related Publications (6)

• Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985.

  PMID: 24170221 RESULT

• Tocco M, Mao Y. Efficacy and Safety of Adding Lurasidone to Ongoing Therapy With Lithium or Valproate for the Treatment of an Acute Bipolar Depressive Episode: A Post Hoc Analysis of 2 Placebo-Controlled Trials. J Clin Psychopharmacol. 2024 Jul-Aug 01;44(4):345-352. doi: 10.1097/JCP.0000000000001850. Epub 2024 Apr 19.

  PMID: 38639433 DERIVED

• 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

• 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

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lurasidone Hydrochloride; Lithium; Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids

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: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 17, 2014
• Results First Posted: April 2, 2013

Record last verified: 2014-03

Locations

IN (11); PL (3); RU (6); DE (1); FR (2); UA (5); RO (6); US (27); ZA (5); CZ (5)