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

Comparative Efficacy and Tolerability of Quetiapine and Clozapine in Treatment Resistant Schizophrenia (TRS)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/02/006660

Enrollment

Registered

2016-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Treatment Resistant Schizophrenia patients

Interventions

Intervention1: Quetiapine: 400-800mg/day in 2 divided doses, orally Control Intervention1: Clozapine: dose of 150-450 mg/day in 2 divided doses, orally

Eligibility

Inclusion criteria

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

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 ).

Design outcomes

Primary

Measure	Time frame
1. To compare the efficacy and tolerability of quetiapine and clozapine in treatment resistant schizophrenia. Timepoint: 14 weeks	—

Secondary

Measure	Time frame
1. To compare the effect of quetiapine and clozapine on quality of life in patients with treatment resistant schizophrenia.Timepoint: 14 weeks	—

Countries

India

Contacts

Public ContactMitesh Kumar

Govenment Medical College and Hospital

ajeetsidana@hotmail.com9646121614

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026