| CTRI Number |
CTRI/2009/091/000643 [Registered on: 30/09/2009] |
| Last Modified On: |
27/08/2014 |
| 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, Placebo Controlled Trial |
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Public Title of Study
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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.
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Scientific Title of Study
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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 |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| D1050235, Amendment # 3 dated October 23, 2009 |
Protocol Number |
| NCT00868452 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Suraj Madhavan |
| Designation |
Associate Clinical Team Lead, |
| Affiliation |
Quintiles Research (India) Private Limited |
| Address |
301-A-1, Leela Business Park,
301-A-1, Leela Business Park, M V Road, Andheri (East)
Mumbai
MAHARASHTRA
400 059
India |
| Phone |
02266774242 |
| Fax |
02266774343 |
| Email |
suraj.madhavan@quintiles.com |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanghamitra Patnaik |
| Designation |
Director Regulatory Affairs |
| Affiliation |
Quintiles Research (India) Pvt Ltd. |
| Address |
, Quintiles Research (India) Pvt Ltd., B-101-106, Shapath IV
Opp.Karnavati Club,Sarkhej- Gandhinagar Road
Ahmadabad
GUJARAT
380051
India |
| Phone |
07966303340 |
| Fax |
07966527272 |
| Email |
Sanghamitra.patnaik@quintiles.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suneela Thatte |
| Designation |
Executive Director |
| Affiliation |
Quintiles Research (India) Pvt. Ltd., |
| Address |
301-A-1 Leela Business Park;
M.V.Road,Andheri (E)
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266774242 |
| Fax |
02266774343 |
| Email |
Suneela.thatte@quintiles.com |
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Source of Monetary or Material Support
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| Dainippon Sumitomo Pharma America, Inc.
1 Bridge Plaza Suite 510,
Fort Lee, NJ 07024
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Primary Sponsor
Modification(s)
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| Name |
Dainippon Sumitomo Pharma America Inc |
| Address |
1 Bridge Plaza Suite 510, Fort Lee, NJ 07024 |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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| Name |
Address |
| Quintiles Research India Pvt Ltd |
B-101-106, Shapath IV Opp. Karnavati Club, Sarkhej-Gandhinagar, Ahmedabad:380051 India |
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Countries of Recruitment
Modification(s)
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Saint Kitts and Nevis
South Africa |
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Sites of Study
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Jitendra kumar Trivedi |
Manobal Medical Research Center Private Limited |
B-8, Sector-A Mahanagar,-226006
Lucknow
UTTAR PRADESH |
0522 2651173
0522 2651173
jktrivedi@hotmail.com |
| Dr.Mahesh Chudgar |
Mental Illness Treatment Rehabilitation Foundation (MITR) |
1, Shantinagar Society,Ashram Road, Vadaj, -380 013
Ahmadabad
GUJARAT |
079 27551755
079 87558623
mahesh_mitr@yahoo.co.in |
| Dr.T.P.Sudhakar |
S.V.Medical College |
S.V.R.R. Government General Hospital,-517501
|
08772286468
08772286499
sudhakartp@yahoo.com |
| Dr.Hitendra Gandhi |
Seth V.S. General Hospital, |
Ellisbridge,-380006
Ahmadabad
GUJARAT |
07926575216
079 26579668
hitengandhi@yahoo.co.in |
| Dr.Mahesh Gowda |
Spandana Nursing Home |
549/ 46. 6th Cross,4th Block, Rajajinagar-560010
Bangalore
KARNATAKA |
080 23114951
080 23141028
maheshrgowda@yahoo.com |
| Dr.Umesh Nagapurkar |
Suyash Hospital |
Ahilyabai Holkar Marg,Mumbai Naka-422002
|
0253 2581663
0253 216189
umeshanjali@gmail.com |
| Dr. Vishal Indla |
Vijayawada Institute of Mental Health and Neuroscience |
29-7-32, V.V Rao Street, Suryaraopet,-520002
|
09704755669
0866-2444999
vishalindla@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethical Committee, Sheth V.S.Hospital |
Approved |
| Ethics Committee ,MITR Foundation |
Approved |
| Independent Ethics Committee |
Approved |
| Institutional Ethics Committee, S.V. Medical college |
Approved |
| North Maharashtra Ethics Committee |
Approved |
| Spandana Ethics Committee |
Approved |
| VIMHANS Hospital Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Bipolar Depression, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Matching Placebo + ((lithium or Divalproex) |
20-120 mg/day |
| Intervention |
Tablet Lurasidone + (lithium or divalproex) |
20-120 mg/day |
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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 |
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 |
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| ExclusionCriteria |
| Details |
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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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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 |
| Mean change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpoint (Week 6) |
Time Frame: 6 weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
| Mean change from baseline to endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) Mean change from baseline to endpoint (Week 6) in: Sheehan Disability Scale (SDS) total score |
Mean change from baseline to endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) [ Time Frame: 6 weeks ] Mean change from baseline to endpoint (Week 6) in: Sheehan Disability Scale (SDS) total score [ Time Frame: 6 weeks ] |
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Target Sample Size
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Total Sample Size="0"
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) |
01/04/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years=""
Months="0"
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 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 target for India : 120 patients. Tentative date of patient enrollment in India: October 01, 2009
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