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Bipolar DepressionPhase 3NCT00868452

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

A Phase 3 study testing lurasidone + (lithium or divalproex) in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 71 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bipolar Depression
What is being tested?
lurasidone + (lithium or divalproex)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
348 participants
Where
71 sitesin 10 countries
Study dates
Apr 2009to Jan 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

71 sites in 10 countries.

71 sites in 10 countries

United States27 sites

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

    Albuquerque, New Mexico, 87109

  • South Coast Clinical Trials, Inc.

    Anaheim, California, 92804

  • University of Colorado

    Aurora, Colorado, 80045

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

    Austin, Texas, 78756

  • Sheppard Pratt Health System,6501 North Charles Street

    Baltimore, Maryland, 21285

  • Catalina Research Institute

    Chino, California, 91710

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Mood Disorders Program-UHCMC

    Cleveland, Ohio, 44106

  • MetroHealth System

    Cleveland, Ohio, 44122

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

    Dayton, Ohio, 45408

  • Synergy Escondido

    Escondido, California, 92025

  • Collaborative Neuroscience Network Inc.,12772 Valley View Street

    Garden Grove, California, 92645

  • Woodland International Research Inc.

    Little Rock, Arkansas, 72211

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

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

    Oak Brook, Illinois, 60523

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

    Oak Brook, Illinois, 60523

  • University of California at Irvine Medical Center

    Orange, California, 92868

  • CRI Worldwide, LLC

    Philadelphia, Pennsylvania, 19139

  • CNRI - Los Angeles LLC,8309 Telegraph Road

    Pico Rivera, California, 90660

  • Lake Charles Clinical Trials LLC,700 Spring Forest Road

    Raleigh, North Carolina, 27609

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

    Raleigh, North Carolina, 27609

  • Capital Clinical Research,5515 Security Lane, Suite 525

    Rockville, Maryland, 20852

  • Midwest Research Group

    Saint Charles, Missouri, 63301

  • CNRI - San Diego, LLC

    San Diego, California, 92102

  • J. Gary Booker, MD

    Shreveport, Louisiana, 71104

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Depression and Anxiety Disorders Research Institue

    Tampa, Florida, 33613

Other trials in United States

India11 sites

  • Samvedna Hospitals

    Ahmedabad, Gujarat, 380006

  • Sheth Vadilal Sarabhai General Hospital

    Ahmedabad, Gujarat, 380006

  • Mental Illness Treatment Rehabilitation Foundation (MITR)

    Ahmedabad, Gujarat, 380013

  • Spandana Nursing Home

    Bangalore, Karna, 560010

  • Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

    Delhi, National Capital Territory of Delhi, 110092

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

    Jaipur, Rajasthan, 302021

  • Shree Hatkesh Health Foundation

    Jūnāgadh, Gujarat, 362001

  • Manobal Med. Research Centre

    Lucknow, Uttar Prad, 226006

  • Sujata Birla Hospital & Research Centre

    Nashik, Mahara, 422101

  • SV Medical College

    Tirupati, Andh Prad, 517507

  • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

    Vijaywada, Andh Prad, 520002

Other trials in India

Romania6 sites

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

    Bucharest, 010825

  • Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

    Bucharest, 041914

  • Spitalul Clinic Judetean de Urgenta Cluj

    Cluj-Napoca, 400012

  • Spitalul Clinic de Neuropsihiatrie Craiova

    Craiova, 200620

  • Spitalul Clinic de Neurologie si Psihiatrie Oradea

    Oradea, 410154

  • Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric

    Piteşti, 110069

Other trials in Romania

Russia6 sites

  • Russian State Medical University

    Moscow, 117997

  • Moscow Medical Academy named I.M. Sechenov

    Moscow, 119435

  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

    Saint Petersburg, 190121

  • Bekhterev Scientific Research Psychoneurological Institute

    Saint Petersburg, 193019

  • Psychoneurology Dispensary #4

    Saint Petersburg, 197110

  • LLC International Medical Centre "SOGAZ"

    Saint Petersburg, 198035

Other trials in Russia

Czechia5 sites

  • Psychiatricka ambulance

    Brno - Mesto, 602 00

  • BIALBI s.r.o. Psychiatricke oddeleni

    Litoměřice, 412 01

  • Clintrial, s.r.o.

    Prague, 10 100 00

  • Medical Services Prague s.r.o.

    Prague, 6 160 00

  • Psychiatricka ambulance Prosek

    Prague, 9 190 00

Other trials in Czechia

South Africa5 sites

  • Cape Trial Centre

    Cape Town, W. Cape, 7530

  • Paarl Medical Centre

    Paarl, W. Cape, 7646

  • Clinika

    Port Elizabeth, E. Cape, 6000

  • Dey Clinic

    Pretoria, Gauteng, 0181

  • Vereeniging Medi-Clinic

    Vereeniging, Free State, 1941

Other trials in South Africa

Ukraine5 sites

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

    Donetsk, 83008

  • Odesa Regional Psychoneurological Dispensary

    Odesa, 65014

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

    Poltava, 36006

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

    Simferopol, 95006

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

    Vinnitsia, 21005

Other trials in Ukraine

Poland3 sites

  • ZOZ Poradnia Zdrowia Psychicznego

    Chełmno, 86-200

  • Praktyka Lekarska Sensorium S.M.O.

    Skorzewo, 60-185

  • Wojewodzki Szpital Brodnowski SP ZOZ

    Warsaw, 03-242

Other trials in Poland

France2 sites

  • Hopital Caremeau, Service de Psychiatrie A

    Nîmes, 30 30029

  • Zans Ritter, Marcel

    Orvault, 44700

Other trials in France

Germany1 site

  • Jana Thomsen

    Berlin BE, 10245

Other trials in Germany

About this study

Official title: A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

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.

Being tested
lurasidone + (lithium or divalproex), Placebo + (lithium or divalproex)
Keywords
Bipolar I, Latuda, Lurasidone
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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

Study groups in NCT00868452
Study groupRoleWhat they receive
LurasidoneExperimentalNot described
Receives: Drug: lurasidone + (lithium or divalproex)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo + (lithium or divalproex)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 6

Secondary outcomes (2)

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

    CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. 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.

    Measured: Baseline Week 6

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

    STS total score ranges from a minimum of 0 to a maximum of 30. 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.

    Measured: Baselin Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00868452
Sponsor's protocol ID
D1050235
Other IDs
EUDRACT No. 2008-007482-23
Status last verified
Mar 2014
First submitted
23 Mar 2009
Last updated
17 Apr 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24170221

  • 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.

    PubMed 38639433

  • 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.

    PubMed 37339360

  • 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.

    PubMed 27529375

  • 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.

    PubMed 27215976

  • 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.

    PubMed 26730454

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lurasidone + (lithium or divalproex) in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 71 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, India, Romania, Russia, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00868452, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.

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