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

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868452
• Other study ID #: D1050235
• Secondary ID: EUDRACT No. 2008
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: March 31, 2014
• Start date: April 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)India: Drugs Controller General of IndiaPoland: The Central Register of Clinical TrialsRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control CouncilUkraine: Ministry of HealthRomania: National Medicines AgencyGermany: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• lurasidone + (lithium or divalproex)
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)
20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7

Locations

Country	Name	City	State
Czech Republic	Psychiatricka ambulance	Brno - mesto
Czech Republic	BIALBI s.r.o. Psychiatricke oddeleni	Litomerice
Czech Republic	Clintrial, s.r.o.	Praha
Czech Republic	Medical Services Prague s.r.o.	Praha
Czech Republic	Psychiatricka ambulance Prosek	Praha
France	Hopital Caremeau, Service de Psychiatrie A	Nimes Cedex
France	Zans Ritter, Marcel	Orvault
Germany	Jana Thomsen	Berlin BE
India	Mental Illness Treatment Rehabilitation Foundation (MITR)	Ahmedabad	Gujarat
India	Samvedna Hospitals	Ahmedabad	Gujarat
India	Sheth Vadilal Sarabhai General Hospital	Ahmedabad	Gujarat
India	Spandana Nursing Home	Bangalore	Karna
India	Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry	Delhi
India	R.K. Yadav Memorial Mental Health & De-Addiction Hospital	Jaipur	Rajasthan
India	Shree Hatkesh Health Foundation	Junagadh	Gujarat
India	Manobal Med. Research Centre	Lucknow	Uttar Prad
India	Sujata Birla Hospital & Research Centre	Nashik	Mahara
India	SV Medical College	Tirupati	Andh Prad
India	Vijayawada Institute of Mental Health and Neurosciences, Psychiatry	Vijaywada	Andh Prad
Poland	ZOZ Poradnia Zdrowia Psychicznego	Chelmno
Poland	Praktyka Lekarska Sensorium S.M.O.	Skorzewo
Poland	Wojewodzki Szpital Brodnowski SP ZOZ	Warszawa
Romania	Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia	Bucuresti
Romania	Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj	Cluj-Napoca
Romania	Spitalul Clinic de Neuropsihiatrie Craiova	Craiova
Romania	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea
Romania	Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric	Pitesti
Russian Federation	Moscow Medical Academy named I.M. Sechenov	Moscow
Russian Federation	Russian State Medical University	Moscow
Russian Federation	Bekhterev Scientific Research Psychoneurological Institute	St. Petersburg
Russian Federation	City Psychiatric Hospital #2 of St. Nikolay Chudotvorets	St. Petersburg
Russian Federation	LLC International Medical Centre "SOGAZ"	St. Petersburg
Russian Federation	Psychoneurology Dispensary #4	St. Petersburg
South Africa	Cape Trial Centre	Cape Town, W. Cape
South Africa	Paarl Medical Centre	Paarl, W. Cape
South Africa	Clinika	Port Elizabeth, E. Cape
South Africa	Dey Clinic	Pretoria, Gauteng
South Africa	Vereeniging Medi-Clinic	Vereeniging, Free State
Ukraine	Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy	Donetsk
Ukraine	Odesa Regional Psychoneurological Dispensary	Odesa
Ukraine	Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM	Poltava
Ukraine	CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1	Simferopol
Ukraine	Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog	Vinnitsia
United States	Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209	Albuquerque	New Mexico
United States	South Coast Clinical Trials, Inc.	Anaheim	California
United States	University of Colorado	Aurora	Colorado
United States	FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200	Austin	Texas
United States	Sheppard Pratt Health System,6501 North Charles Street	Baltimore	Maryland
United States	Catalina Research Institute	Chino	California
United States	University of Cincinnati	Cincinnati	Ohio
United States	MetroHealth System	Cleveland	Ohio
United States	Mood Disorders Program-UHCMC	Cleveland	Ohio
United States	Midwest Clinical research Center, One Elizabeth Place, Suite G-3	Dayton	Ohio
United States	Synergy Escondido	Escondido	California
United States	Collaborative Neuroscience Network Inc.,12772 Valley View Street	Garden Grove	California
United States	Woodland International Research Inc.	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	American Medical Research Inc.,1200 Harger Road Suite 415	Oak Brook	Illinois
United States	American Medical Research, Inc., 1200 Harger Road Suite 415	Oak Brook	Illinois
United States	University of California at Irvine Medical Center	Orange	California
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	CNRI - Los Angeles LLC,8309 Telegraph Road	Pico Rivera	California
United States	Lake Charles Clinical Trials LLC,700 Spring Forest Road	Raleigh	North Carolina
United States	Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125	Raleigh	North Carolina
United States	Capital Clinical Research,5515 Security Lane, Suite 525	Rockville	Maryland
United States	CNRI - San Diego, LLC	San Diego	California
United States	J. Gary Booker, MD	Shreveport	Louisiana
United States	Midwest Research Group	St. Charles	Missouri
United States	Stanford University School of Medicine	Stanford	California
United States	Depression and Anxiety Disorders Research Institue	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Czech Republic,  France,  Germany,  India,  Poland,  Romania,  Russian Federation,  South Africa,  Ukraine, 

References & Publications (1)

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;17 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline Week 6	No
Secondary	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.	Baselin Week 6	No