CTRI/2017/11/010391CompletedNot Applicable
Early response to antipsychotics as a predictor to later response in non affective psychosis
Goverment Medical College and Hospital1 site in 1 country60 target enrollmentStarted: December 20, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1.Identify the early responder and non responder
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.Identify the early responder and non responder
Time Frame: 1t week,2nd week,4th week,6th week,8th week.
2.the response rate amongst the early non-responders after either continuing on the same antipsychotic or being switched over to another atypical antipsychotic
Time Frame: 1t week,2nd week,4th week,6th week,8th week.
Secondary Outcomes
- 20% Reduction in the illness severity on PANSS.(2nd week)
Investigators
Study Sites (1)
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