| CTRI Number |
CTRI/2017/11/010391 [Registered on: 06/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Delayed Response to Antipsychotic Medication in Psychosis
|
|
Scientific Title of Study
|
Early response to antipsychotics as a predictor to
later response in non affective psychosis
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anadrika Debbarma |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Goverment Medical College and Hospital |
| Address |
Psychiatry Office,level -5,D-Block,Goverment Medical College and Hospital Sector 32 A
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8413092529 |
| Fax |
|
| Email |
anadrikadb@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BS Chavan |
| Designation |
Professor and Head of Department |
| Affiliation |
Goverment Medical College and Hospital |
| Address |
Psychiatry Office,Level5,D Block,Goverment Medical College and Hospital,Sector 32 A
Goverment Medical College and Hospital Sector 32 A
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121611 |
| Fax |
|
| Email |
drchavanbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BS Chavan |
| Designation |
Professor and Head of Department |
| Affiliation |
Goverment Medical College and Hospital |
| Address |
Psychiatry Office,Level5,D Block,Goverment Medical College and Hospital,Sector 32 A
Goverment Medical College and Hospital Sector 32 A
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121611 |
| Fax |
|
| Email |
drchavanbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Goverment Medical College and Hospital |
| Address |
Goverment Medical College and Hospital,Sector 32 A Chandigarh-160030 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anadrika Debbarma |
Goverment Medical College and Hospital |
Psychiatry Department,Govt.Medical College and Hospital,Sector 32 A
Chandigarh
CHANDIGARH |
8413092529
anadrikadb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Non Affective Psychosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug Risperidone and Olanzapine |
Risperidone 2-8 mg/day for 8 week.
Olanzapine 10-30mg/day for 6 weeks. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient should meet the following psychopathology severity criteria at the time of inclusion into the study
1.total score extracted from Positive and Negative Syndrome Scale should be atleast 45
2. A score of atleast 4 [moderate] on at least 2 of following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior and unusual thought content
3.Patient who are either drug naïve or who had relapsed in preceding 2 weeks requiring change in medications.
|
|
| ExclusionCriteria |
| Details |
1.Patient with history of inadequate response to risperidone or olanzapine in the past.
2.Patient with history of allergic reaction to risperidone or olanzpine
3.History of use of risperidone or olanzapine with in past 30 days before the study enrolment.
4.Acute, serious or unstable co-morbid medical condition
5.Schizo-affective disorder
6.Active substance dependence except nicotine and caffeine
7.Pregnant and lactating women
8.Treatment resistant schizophrenia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Identify the early responder and non responder
2.the response rate amongst the early non-responders after either continuing on the same antipsychotic or being switched over to another atypical antipsychotic |
1t week,2nd week,4th week,6th week,8th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 20% Reduction in the illness severity on PANSS. |
2nd week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2015 |
| Date of Study Completion (India) |
01/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published anywhere. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Present Study is planned to see Whether Early response to Anti-psychotics is a predictor to later reponse to Antipsychotics in Non Affective Psychosis.Two Antipsychotics were used. Response will be seen in this follow up study of 8 weeks. |