Role of Quetiapine and Clozapine in Treatment Resistant Schizophrenia (TRS)

Phase 4

Completed

Conditions: Health Condition 1: null- Treatment Resistant Schizophrenia patients

Registration Number: CTRI/2016/02/006660

Lead Sponsor: Mitesh Kumar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1)Patients suffering from schizophrenia as per ICD 10 (Diagnostic Criteria for Research ) criteria and fulfilling modified version of Conley and Kellyâ??s criteria of Treatment Resistant Schizophrenia(TRS) which is defined as:

a) No clinical response with two different antipsychotics used separately in the dose range of 400â??600 mg of chlorpromazine per day or equivalents for 6 weeks,

b) no period of good social or occupational functioning at least in last one year, plus a minimum Clinical Global Impressions (CGI) Scale rating of 4 (moderately ill),

c)BPRS total score > 45, and a score of >4 on 2 of 4 positive items.

2) Patients who are accompanied by reliable informants.

3) Patients and relatives willing to give informed consent

Exclusion Criteria

1) Patients of co-morbid substance dependence except nicotine use.

2) Patients who have received clozapine or quetiapine in the past.

3) Patients with sub normal intelligence.

4) Patient with heart conduction defects, history of agranulocytosis or TLC less than 3500 per mm3

and pre-existing diabetes mellitus, hypertension.

5) Patient with neurological disorders such as head injury, epilepsy, movement disorder and tumours.

6) Pregnant and lactating mother.

7) Patient with late onset schizophrenia ( after 45 years ).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the efficacy and tolerability of quetiapine and clozapine in treatment resistant schizophrenia. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 14 weeks

Secondary Outcome Measures