| CTRI Number |
CTRI/2009/091/000288 [Registered on: 10/06/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effects of Lurasidone HCl in patients with acute schizophrenia |
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Scientific Title of Study
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A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects with Schizophrenia (PEARL 3)
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| D1050233 |
Protocol Number |
| NCT00790192 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Ketan Deshpande |
| Designation |
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| Affiliation |
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| Address |
Quintiles Research (India) Private Limited, Leela Business Park,
M.V Road, Marol ,Andheri (East)
Mumbai
MAHARASHTRA
400059
India |
| Phone |
022-66774310 |
| Fax |
022-6677 4343 |
| Email |
Ketan.Deshpande@Quintiles.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanghamitra Patnaik |
| Designation |
|
| Affiliation |
Quintiles Research (India) Pvt. Ltd. |
| Address |
Director Regulatory Affairs, Quintiles Research (India) Private Limited
B-101-106, Shapath IV
Ahmadabad
GUJARAT
380 051
India |
| Phone |
079 66303340 |
| Fax |
079 66303366 |
| Email |
sanghamitra.patnaik@quintiles.com |
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Details of Contact Person
Public Query
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| Name |
Suneela Thatte |
| Designation |
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| Affiliation |
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| Address |
Executive Director Clinical Operations, Quintiles Research (India) Private Limited
301-A-1 Leela Business Park
Mumbai
MAHARASHTRA
400059
India |
| Phone |
022 66774242 |
| Fax |
022 66774343 |
| Email |
suneela.thatte@quintiles.com |
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Source of Monetary or Material Support
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| Dainippon Sumitomo Pharma America, Inc.,
One Bridge Plaza,
Suite 510, Fort Lee,
NJ 07024, USA |
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Primary Sponsor
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| Name |
Dainippon Sumitomo Pharma America, Inc.,
One Bridge Plaza,
Suite 510, Fort Lee,
NJ 07024, USA
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sanjay Phadke, |
Deenanath Mangeshkar Hospital and Research Centre |
Erandwane,-411 004
Pune
MAHARASHTRA |
020-40151000
020-25420104
sanjay_phadke@hotmail.com |
| Dr. Keshava Pai, |
Dept. of Psychiatry, Kasturba Medical College (KMC) |
Attavar,-575 001
Bangalore
KARNATAKA |
0824 - 242 7298
0824-2425092
paikeshava@hotmail.com |
| Dr. Sathyanarayana Rao |
JSS Medical College Hospital, |
Department of Psychiatry,Ramanuja Road,-570004
Mysore
KARNATAKA |
08212-563845
08212-08212442840
tssrao19@yahoo.com |
| Dr. Satheesh Rao, |
Justice K.S. Hegde Charitable Hospital |
Department of Psychiatry,,Post Nityanand Nagar,-574 160
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0824-2202733
0824-2202733
dr_satheeshrao@yahoo.com |
| Dr. R. Sathianathan |
Madras Medical College & Government General Hospital |
Department of Psychiatry,-600 003
Chennai
TAMIL NADU |
044-2538 8989
044-2538 8989
sathianathen6@yahoo.com |
| Dr. Prakash Behere |
Mahatma Gandhi Institute for Medical sciences |
Sevagram,-442102
Wardha
MAHARASHTRA |
0891-2724347
0891-2724348
pbbehere@gmail.com |
| Dr. Sandeep Shah |
SBKS Medical Institute and Research Centre |
Dhiraj General Hospital,-391760
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0265 2435283
0265 2430464
BRIJCLINIC@REDIFFMAIL.COM |
| Dr. Hitendra Gandhi |
Seth V.S. General Hospital Department of Psychiatry |
Ellisbridge,-380006
Ahmadabad
GUJARAT |
079-26579668
079-26576652
hitengandhi@yahoo.co.in |
| Dr. V.L. Barhale |
Shanti Nursing Home |
Kanchanwadi,Paithan Road-431005
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0240-2376271
0240-2377631
vinay.barhale@rediffmail.com |
| Dr. Padma Sudhakar Thatikonda |
Sri Venkateswara Medical College |
Department of Psychiatry,-517507
|
0877-22886468
0877-2286499
sudhakartp@yahoo.com |
| Dr. Vishal Indla |
Vijayawada Institute of Mental Health and Neurosciences |
29-7-32, V.V. Rao Street,,Surya Rao Pet, -520002
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0866-2432040
0866-2432040
vishalindla@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee -Sumandeep Vidyapeeth University Ethics Committee |
Approved |
| Ethics Committee Kasturba Medical College |
Approved |
| Ethics Committee MGIMS, Sevagram |
Approved |
| Ethics Committee- Jagadguru Sri Shivarathreeshwara Medical college |
Approved |
| Ethics Committee- Vijaywada Institute of Mental Health and Neurosciences Hospital |
Approved |
| Ethics Committee-Shanti Nursing Home |
Approved |
| Ethics Committee; Seth Vadilal Sarabhai General Hospital |
Approved |
| Institutional Ethics Commitee - Sri Venkateswara Medical College |
Approved |
| Institutional Ethics Commitee; Deenanath Mangeshkar Hospital & Research Centre |
Submittted/Under Review |
| KSHEMA Ethics Committee; K.S Hegde Medical Academy |
Approved |
| The Ethics Committee; Madras Medical College and Government General Hospital |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Acute schizophrenia, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Placebo of Lurasidone |
OD |
| Comparator Agent |
Quetiapine XR |
600 mg OD |
| Intervention |
Tablet Lurasidone |
160 mg OD |
| Intervention |
Tablet Lurasidone |
80 mg OD |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Main Inclusion Criteria:
Subject is 18 to 75 years of age on the day of signing informed consent.
Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), or undifferentiated (295.90) subtypes as established by clinical interview (using the Mini-International Neuropsychiatric Interview [MINI] Plus diagnostic interview and the DSM-IV-TR as a reference). The duration of the subject?s illness whether treated or untreated must be greater than 1 year.
Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening. Subjects who have been hospitalized for more than 2 weeks for reasons unrelated to acute exacerbation can be included with concurrence from the Medical Monitor that such hospitalization was for a reason other than acute relapse. For example, subjects in long-term hospitals (e.g., for years) who have a clear acute exacerbation and are transferred to an acute unit (for 2 weeks or less) are suitable for this protocol.
Subject has a PANSS total score ≥80 at screening and baseline, with a score ≥4 (moderate) on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content.
Subject has a score ≥4 on the CGI-S at screening and baseline.
Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.
Subject has had a stable living arrangement for at least 3 months prior to randomization and agrees to return to a similar living arrangement after discharge. 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. The Medical Monitor should be consulted for individual cases as needed.
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| ExclusionCriteria |
| Details |
Main Exclusion Criteria
Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject has a prolactin concentration >100 ng/mL at screening or has a history of pituitary adenoma.
Subject has a history of hypersensitivity to quetiapine.
Subject has used quetiapine within 30 days prior to Screening and/or has a history of inadequate response or intolerability to quetiapine.
Subject is resistant to neuroleptic treatment, defined as failure to respond to 2 or more marketed antipsychotic agents from 2 different classes, given at an adequate dose for at least 6 weeks.
Subject has received depot neuroleptics unless the last injection was at least 1 treatment cycle before randomization.
Subject has a history of treatment with clozapine for refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of randomization.
Subject has received treatment with mood stabilizers or antidepressants within 1 week, fluoxetine hydrochloride at any time within 1 month, or a monoamine oxidase (MAO) inhibitor with 3 weeks of randomization.
Subject will require treatment with any potent cytochrome P450 3A4 (CYP3A4) inhibitors or inducers during the study. Subject requires treatment with a drug that prolongs the QT interval corrected for individual heart rate (QTc interval).
The subject demonstrates a decrease (improvement) of >20% in the PANSS score between the screening and baseline visits, or the PANSS score falls below 80 at baseline.
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Other |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Primary Efficacy Endpoint: Mean change from baseline in total PANSS score at endpoint (Week 6). Outcome Name: Primary Safety Endpoints: The proportion of subjects with: Adverse Events (AEs),Discontinuations due to AEs, Serious Adverse Events (SAEs) |
Baseline, Week 6 |
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Secondary Outcome
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| Outcome |
TimePoints |
| Key Secondary Efficacy Endpoints: Mean change from baseline in:CGI-S score o PANSS total score on Day 4 |
Day 4 |
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Target Sample Size
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Total Sample Size="480"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/10/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a phase III, six-week, multi-center, randomized, double-blind, placebo-controlled study to examine the safety and efficacy of Lurasidone in the Acutely Psychotic Subjects with Schizophrenia. Lurasidone will be administered in tablet form, once daily by mouth in 80 and 160 mg doses. Placebo will be administered with visibly matching tablets, using the same route and regimen. Approximately 480 subjects will be randomized during the study from 70 sites all over the world. Approximately 200 subjects will be randomized during the study from 11 sites in India |