PEARL Schizophrenia Maintenance

NCT01435928 | Completed Phase 3 Results DMC

• 1 other identifier: D1050238
• Study Type: interventional
• Target: 676
• Locations: 7 countries
• Sites: 75

Brief Summary

Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Lurasidone; Latuda

Outcome Measures

Primary Outcomes (1)

• Time to First Relapse Event During Double-blind Phase

  The Kaplan-Meier method is used for the estimation.

  Double-blind phase - 28 Weeks

Secondary Outcomes (9)

• Time to All-cause Discontinuation

  Double-blind phase - 28 weeks

• Change From Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

  Double-Blind phase - 28 Weeks

• Change From Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score

  Double-blind phase - 28 Weeks

• Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  Double-blind phase - 28 Weeks

• Change From Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score

  Double-blind phase - 28 Weeks

Other Outcomes (1)

• EuroQol (EQ-5D): EQ-VAS Score

  Double-blind phase - 28 Weeks

Study Arms (2)

Lurasidone

EXPERIMENTAL

Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating

Drug: Lurasidone

Placebo

PLACEBO COMPARATOR

Matching placebo once daily in the evening with a meal or 30 minutes after eating

Drug: Matching Placebo

Interventions

Lurasidone DRUG

Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating

Also known as: Latuda

Lurasidone

Matching Placebo DRUG

Matching placebo once daily in the evening with a meal or 30 minutes after eating

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:

• Open Label:
• Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
• Subject is ≥ 18 and ≤ 75 years of age, on the day of signing the informed consent.
• Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia \[including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes as established by clinical interview (using the DSM-IV-TR as a reference and confirmed using the SCID-CT)\]. The duration of the subject's illness whether treated or untreated must be ≥ 1 year.
• Subject has had at least one prior episode of psychotic exacerbation as judged by the Investigator in the two years preceding screening.
• Subject has a PANSS Total score ≥ 80 with a score ≥ 4 on 1 or more of any PANSS Positive subscale items at screening and open-label baseline (Visit 2).
• Subject has a CGI-S score of ≥ 4 at screening and open-label baseline (Visit 2).
• Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
• Female subject of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of lurasidone has been taken. In the Investigator's judgment, the subject will adhere to this requirement.
• Adequate contraception is defined as continuous use of either two barrier methods (e.g., condom and spermicide or diaphragm with spermicide) or a hormonal contraceptive. Acceptable hormonal contraceptives include the following: a) contraceptive implant (such as Norplant®) implanted at least 90 days prior to screening; b) injectable contraception (such as medroxyprogesterone acetate injection) given at least 14 days prior to screening; or c) oral contraception taken as directed for at least 30 days prior to screening.
• Subjects who are of non-reproductive potential, i.e., subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) concentrations within postmenopausal range as determined by laboratory analysis) are not required to remain abstinent or use adequate contraception.
• Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.
• Subject has had a stable living arrangement at the time of screening and agrees to return to a similar living arrangement after discharge, if hospitalized. This criterion is not meant to exclude subjects who have temporarily left a stable living arrangement (e.g., due to psychosis). Such subjects remain eligible to participate in this protocol. Chronically homeless subjects should not be enrolled.
• Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
• Subject who requires concomitant medication treatment with the following agents may be included if they have been on stable doses (i.e., minor adjustments only) for the specified times: 1) antidepressant agents (except fluvoxamine) and/or mood stabilizers (except carbamazepine or oxcarbazepine) must be stable for at least 30 days prior to open-label baseline, 2) oral hypoglycemics must be stable for at least 30 days prior to screening, 3) antihypertensive agents must be stable for at least 30 days prior to screening, and 4) thyroid hormone replacement must be stable for at least 90 days prior to screening. (Note: CYP3A4 inducers and inhibitors will not be allowed).

You may not qualify if:

• Open Label - Subject has a DSM-IV Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
• Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (in the past month) or baseline.
• Subject has attempted suicide within 3 months prior to the screening phase. Subject currently has a clinically significant medical condition including the following: neurological, metabolic (including Type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with human immunodeficiency virus (HIV) seropositivity (or history of seropositivity) will be excluded.
• Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.
• Note: Subjects with serum alanine transaminase (ALT) or aspartate transaminase (AST) levels ≥ 3 times the upper limit of the reference ranges provided by the central laboratory require retesting. If on retesting, the laboratory value remains ≥ 3 times the upper limit, such subjects will be discussed with the Medical Monitor for enrollment consideration.
• Subject has a history of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug.
• Subject with Type 1 or Type 2 insulin-dependent diabetes.
• if a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.
• Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator. Subjects with a fasting blood glucose at screening ≥ 126 mg/dL (7.0 mmol/L) or HbA1c ≥ 7.0% will be excluded.
• Note: Subjects with random (non-fasting) blood glucose at screening ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state.
• Subject has a prolactin concentration \> 100 ng/mL at screening or has a history of pituitary adenoma.
• Subject has a history of malignancy \< 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
• Subject is judged to be resistant to antipsychotic treatment defined as any one of the following:
• failure to respond to \> 2 marketed antipsychotic agents, given at an adequate dose and for an adequate duration (within the past 2 years)
• history of treatment with clozapine for refractory psychosis Subject is unlikely to achieve a stable condition for ≥ 12 weeks during the open-label lurasidone phase based on the totality of evidence from the psychiatric history and/or the current presentation.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (75)

Woodland Research Northwest

Springdale, Arizona, 72764, United States

Location

K&S Professional Research

Little Rock, Arkansas, 72201, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Comprehensive Clinical Development Inc.

Cerritos, California, 90703, United States

Location

Diligent Clinical Trials

Downey, California, 90241, United States

Location

Synergy Escondido

Escondido, California, 92025, United States

Location

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Excell Clinical Trials

Oceanside, California, 92056, United States

Location

CNRI - Los Angeles LLC,8309 Telegraph Road

Pico Rivera, California, 90660, United States

Location

California Neuropsychopharmacology Clinical Research Instit

San Diego, California, 92102, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Collaborative Neuroscience Network Inc.

Torrance, California, 90502, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Accurate Clinical Trials

Kissimme, Florida, 34742, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Comprehensive NeuroScience, Inc.

Atlanta, Georgia, 30328, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Lousiana Clinical Research, LLC

Shreveport, Louisiana, 71104, United States

Location

CBH Health LLC

Rockville, Maryland, 20850, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

Psych Care Consultants Research

St Louis, Missouri, 63128, United States

Location

Horne Research

Las Vegas, Nevada, 89102, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

CRI Worldwide LLC

Willingboro, New Jersey, 08046, United States

Location

University of New York, Dept. of Psychiatry

Buffalo, New York, 14218, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Comprehensive Clinical Development, Inc

Fresh Meadows, New York, 11366, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, 10305, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Oklahoma Clinical Research

Oklahoma City, Oklahoma, 73116, United States

Location

CRI Worldwide LLC at Kirkbride

Philadelphia, Pennsylvania, 19139, United States

Location

Lincoln Research

Lincoln, Rhode Island, 02865, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

FutureSearch Clinical Trials LP

Austin, Texas, 78756, United States

Location

FutureSearch Clinical Trials, LP

Dallas, Texas, 75231, United States

Location

Pillar Clinical Research LLC

Dallas, Texas, 75243, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381, United States

Location

Department of Psychiatry, University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Frontier Institute

Spokane, Washington, 99204, United States

Location

CHU Clermont-Ferrand - CMP B

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Specialise du Jura - Centre Medico Psychiatric

Dole, 39100, France

Location

Centre Hospitalier Guillaume Regnier

Rennes, 35703, France

Location

Hopital Chalucet, Centre hospitalier intercommunal de toulon la Seyne sur mer (CHITS)

Toulon, 83000, France

Location

Cabinet Medical

Toulouse, 31200, France

Location

SC SPDC-Edificio n. 7, Ospedale S. Andrea

La Spezia, 19123, Italy

Location

Dipartimento Salute Mentale ASL 1

Massa, 54100, Italy

Location

A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

Pisa, 56100, Italy

Location

Regional Government Institution Kipetsk Regional Psychoneurology Hospital

Lipetsk, 399083, Russia

Location

Limited Liability Company (LLC) Research Center for Treatment and rehabilitation "Phoenix"

Rostov-on-Don, 344000, Russia

Location

City Psychoneurological Dispensary #7 (with Hospital)

Saint Petersburg, 190005, Russia

Location

St. Petersburg State Budgetary Healthcare Institution City Psychoneurology Dispensary #7 (with in-patient dept.) (SPb SBHI CPNDD-7), at daycare facility #1

Saint Petersburg, 19005, Russia

Location

St. Petersburg State Healthcare Institution (SPbSH) "City Psychiatric Hospital #6"

Saint Petersburg, 191167, Russia

Location

St. Petersburg State Government Healthcare Institution City Psychiatric Hospital #4 (St. Petersburg Insane Asylum Distributor)

Saint Petersburg, 19119, Russia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

Military Medical Academy, Clinic for Psychiatry

Belgrade, 11000, Serbia

Location

Clinical Centre Kragujevac, Clinic for Psychiatry

Kragujevac, 34000, Serbia

Location

Clinical Centre Nis, Clinic for mental health protection

Niš, 18000, Serbia

Location

Specialized Hospital for psychiatric diseases "Sveti Vracevi"

Novi Kneževac, 23330', Serbia

Location

Clinical Centre Vojvodina, Clinic for Psychiatry

Novi Sad, 21000, Serbia

Location

Nemonnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

Bojnice, 972 01, Slovakia

Location

Psychiatricka ambulancia Mentum, s.r.o.

Bratislava, 82007, Slovakia

Location

Psychiatricka nemocnica Michalovce

Michalovce, 071 01, Slovakia

Location

PsychoLine s.r.o. Psychiatricka ambulancia

Rimavská Sobota, 97901, Slovakia

Location

Psychiaticke oddelenie Vseobecna nemocnica Riimavska Sobota, NaP n.o.

Rimavská Sobota, 97912, Slovakia

Location

Psychiatricke oddelenie, Nemocnica s poliklinikou sv. Barbory Roznava, a.s.

Rožňava, 048 01, Slovakia

Location

Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia

Svidník, 08901, Slovakia

Location

Research Unit, Department of Psychiatry Free State Psychiatric Complex

Bloemfontein, 9300, South Africa

Location

Cape Trial Centre

Cape Town, W. Cape, 7530, South Africa

Location

Denmar Hospital Consulting Rooms

Pretoria, 0081, South Africa

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic 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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 8, 2016
• Results First Posted: September 25, 2014

Record last verified: 2016-03

Locations

ZA (3); FR (5); RU (6); IT (3); SL (7); US (45); SE (6)