| CTRI Number |
CTRI/2009/091/001040 [Registered on: 21/04/2010] |
| Last Modified On: |
12/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Clinical Trial to study the Effect of TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients With Cognitive Dysfunction in Schizophrenia. |
Scientific Title of Study
Modification(s)
|
A Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients with Cognitive Dysfunction in Schizophrenia |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT01003379 |
ClinicalTrials.gov |
| PRO-05619-CRD-001 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Gundugurthi Prasad Rao |
| Designation |
Principal Investigator |
| Affiliation |
Asha Hospital |
| Address |
Asha Hospital, # L98, Road No. 14, Banjara Hills
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
91-40-66752222 |
| Fax |
91-40-66759658 |
| Email |
prasad40@gamil.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Naveena A DCor |
| Designation |
Medical Safety Officer |
| Affiliation |
QED Pharmaceutical Services Pvt. Ltd. |
| Address |
QED Pharmaceutical Services, Pvt. Ltd., Plot No. 8-2-684/4/16, Road No.12, Anand Banjara Lane, Banjara Hills,
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
91-40-23304916 |
| Fax |
91-40-23304917 |
| Email |
naveena.dcor@qedpharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Capt A Venkat Rao |
| Designation |
Director Operations |
| Affiliation |
QED Pharmaceutical Services, Pvt. Ltd. |
| Address |
QED Pharmaceutical Services, Pvt. Ltd., Plot No. 8-2-684/4/16, Road No.12, Anand Banjara Lane, Banjara Hills,
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
91-40-23302723 |
| Fax |
91-40-23304917 |
| Email |
rao.ancha@qedpharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Targacept, Inc., 200 East First Street, Suite 300 Winston-Salem, North Carolina 27101-4165, USA |
|
Primary Sponsor
Modification(s)
|
| Name |
TargaceptInc |
| Address |
200 East First Street, Suite 300 Winston-Salem, NC 27101-4165, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.P.K. Kiran Kumar |
Adhit Kiran Neuropsychiatric Centre |
First Floor, Millenium Towers,Opp. Highland Hospital ,-575002
Bangalore
KARNATAKA |
+918242430400
+918244250400
drkirana@hotmail.com |
| Dr Gundugurthi Prasad Rao |
Asha Hospital |
Asha Hospital, # L98, Road No. 14, Banjara Hills -500034
Hyderabad
ANDHRA PRADESH |
91-40-66752222
91-40-66759858
prasad40@gmail.com |
| Dr Ramanand Satapathy |
Brain Mind Behaviour Neurosciences Research Institute |
201, MVV Chambers, Opp. KGH , Clock Tower-530002
Visakhapatnam
ANDHRA PRADESH |
91-891-2713545
91-891-2713686
drramanand@yahoo.co.in |
| Dr Vivek Agarwal |
CSM Medical University |
Shahmina Road, Lucknow-226003
Lucknow
UTTAR PRADESH |
91-522-2651241
91-522-2651241
drvivekagarwal06@gmail.com |
| Prof Thatikonda Padma Sudhakar |
Dept. of Psychiatry, SV Medical College |
Alipiri Road, Tirupati-517507
Chittoor
ANDHRA PRADESH |
91-877-2286568
91-877-2286499
sudhakartp@gmail.com |
| Dr N Nooka Raju |
Government Hospital for Mental Care |
China Waltair-530017
Visakhapatnam
ANDHRA PRADESH |
91-891-2724347
91-891-2724348
drnnraju@yahoo.com |
| Dr T S Satyanarayana Rao |
JSS Medical College & Hospital |
Department of Psychiatry, JSS Medical College & Hospital, MG Road-57004
Mysore
KARNATAKA |
91-821-2442840
91-821-2442840
tssrao19@gmail.com |
| Dr R K Mahendru |
Mahendru Psychiatric Centre |
117/40, Sarvodaya Nagar,Kanpur-208005
Kanpur Nagar
UTTAR PRADESH |
91-512-2233838
91-512-2234101
rkmahendru@indiatimes.com |
| Dr P Ramakrishna |
Owaisi Hospital & Research Centre |
Santoshnagar, DMRL X roads, P.O Kanchanbagh-500058
Hyderabad
ANDHRA PRADESH |
91-40-23731142
91-40-24342596
dr_p_ramakrishna@yahoo.com |
| Dr Dattatreya M Dhavale |
Poona Hospital & Research Centre |
27, Sadashivpet,Pune-411030
Pune
MAHARASHTRA |
91-20-25535079
91-20-24338477
dattatreyad@yahoo.com |
| Dr K Suresh Kumar |
Sravani Polyclinic and Mental Health Care Centre |
1st line, Sambasivapet,Guntur-522001
Guntur
ANDHRA PRADESH |
91-863-2222009
91-863-2320559
kotasureshkumar99@yahoo.co.in |
| Dr Vishal Indla |
Vijayawada Institute of Mental Health and Neurosciences (VIMHANS) |
V.V.Rao Street, Suryaraopet, Vijayawada-520002
Krishna
ANDHRA PRADESH |
91-866-2432040
91-866-2444999
vishalindla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Canara Research Ethical Committee, Mangalore |
Approved |
| Ethics Committee, Asha Hospital,Hyderabad |
Approved |
| Ethics Committee, JSS Medical College, Mysore |
Approved |
| Ethics Committee, Poona Hospital & Research Centre, Pune |
Approved |
| Ethics Committee, Sravani Polyclinic and Mental Health Care,Guntur |
Approved |
| Institutional Ethics Committee, Andhra Medical College, Vishakapatnam |
Approved |
| Institutional Ethics Committee, Andhra Medical College, Vishakapatnam |
Approved |
| Institutional Ethics Committee, CSM Medical University, Lucknow |
Approved |
| Institutional Ethics Committee, Deccan College of Medical sciences & Allied Hospitals, Centre for Liver Research & Diagnostics,Hyderabad |
Approved |
| Institutional Ethics Committee, S.V. Medical College, Tirupati |
Approved |
| Mahendru Psychiatric Centre Ethics Committee,Kanpur |
Approved |
| Vijayawada Institute of Mental Health & Neurosciences Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Cognitive Dysfunction in Schizophrenia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Once daily single oral dose for 12 weeks |
| Intervention |
TC-5619 |
Total duration of treatment period is 12 weeks. Once daily single oral dose of 1 mg, 5 mg or 25 mg. Each dosage will be given for a period of 4 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of schizophrenia, per DSM-IV TR criteria, as aided by the MINI International Neuropsychiatric Interview (MINI)
2.Controlled schizophrenia, on same dose of quetiapine or risperidone for no less than 2 months prior to screening
3.Age 18 - 60, male or female
4.Stable schizophrenia as documented by lack of psychiatric hospitalization for 2 months prior to Screening
5.Clinical history of stable psychotic symptoms for 1 month prior to Screening
6.Stable positive symptoms of schizophrenia for 4 weeks prior to Day 1, as shown by score ≤ 4 on PANSS for items related to delusion, hallucination, conceptual disorganization, and unusual thought content, at Screening and at Day 1
7.Calgary Depression Scale for Schizophrenia score < 6
8.Outpatient with stable housing, and presence of an informant who sees the subject at least 4 times weekly
9.Able to understand and sign informed consent |
|
| ExclusionCriteria |
| Details |
1. Diagnosis of schizoaffective or schizophreniform disorders 1 year prior to Screening
2. Patients at significant risk of suicide or of danger to themselves or others
3. Antipsychotics other than quetiapine or risperidone, or a change in dosing of these within 2 months of Screening
4. Treatment with mood stabilizers, antidepressants, or anxiolytics (short-acting hypnotics permitted)
5. Treatment within 1 month using cognition-affecting agents other than the above, as listed in Appendix 3 (e.g.
CNS stimulants)
6. Use of other prohibited concomitant medications
7. Other concomitant medications that have been changed within 1 month prior to Screening
8. History within past 6 months of alcohol or illicit drug abuse
9. Use of smoking cessation therapy within 1 month prior to Screening
10. Tobacco users with no detectable urine cotinine level; and tobacco non-users with a detectable urine cotinine
level > than 50ng/mL (urine cotinine level between 50ng/ml and 500ng/ml will be excluded)
11. Unable to comply with study procedures in opinion of investigator, including CogState battery
12. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary,
cardiovascular, gastrointestinal, or urological disorder
13. History of myocardial infarction
14. History of seizure disorder
15. Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed, with HbA1C < 7.3)
16. Electroconvulsive therapy within 2 months prior to Screening
17. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency
18. Current TB or known systemic infection (HBV, HCV, HIV)
19. Clinically significant finding on physical exam that could be a safety issue in the study
20. ALT or AST levels > 2.5 times the upper limits of the laboratory reference range
21. Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450
(males) or QTcF > 480msec (females)
22. Women of child-bearing potential and men unwilling or unable to use accepted methods of birth control
23. Women with a positive pregnancy test, or who are lactating
24. Participation in another clinical trial in last 3 months prior to Screening
25. Involvement in planning or conduct of the study by site staff
26. Body Mass Index (BMI) < 15 and > 31 without prior approval from the medical monitor
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| ?To assess the efficacy of TC-5619 as augmentation therapy to quetiapine or risperidone, to improve cognition in stable outpatients with Cognitive Dysfunction in Schizophrenia (CDS), using the CogState Schizophrenia Test Battery (CSTB). |
Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| ?Assess the efficacy, safety and tolerability of TC-5619 administered adjunctively with quetiapine or risperidone, evaluate the pharmacokinetics of TC-5619 and plasma levels of quetiapine and risperidone/9-OH-risperidone. |
Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="185"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
10/03/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
27/10/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a multi-center, double blind, randomized, placebo-controlled, parallel group, study that will be conducted in five centers in the US and in twelve centers India. No more than 200 subjects will be enrolled in the study (to ensure 120 complete) with 50% of the subjects being tobacco users and 50% being non-tobacco users. In India up to 150 subjects will be enrolled in the study. Screening of subjects for the study in India is expected to start from first week of January 2010 and enrollment of the first subject in India is expected to be from the first week of February 2010 as there is a 4-week screening period before enrollment in the study. Since there is no approved treatment for CDS, a placebo-controlled study is appropriate. There will be 3 phases of the study: Screening (Week -4 to Day 1); Treatment (Day 1 - Week 12); and Follow-up (Week 12- Week 14). Primary Outcome Measures: ?To assess the efficacy of TC-5619 as augmentation therapy to quetiapine or risperidone, to improve cognition in stable outpatients with Cognitive Dysfunction in Schizophrenia (CDS), using the CogState Schizophrenia Test Battery (CSTB). [ Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period. ] Secondary Outcome Measures: ?Assess the efficacy, safety and tolerability of TC-5619 administered adjunctively with quetiapine or risperidone, evaluate the pharmacokinetics of TC-5619 and plasma levels of quetiapine and risperidone/9-OH-risperidone. [ Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period. ] |