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To study the difference in effect of various drug in patient suffering from Schizophrenia, a kind of mental disorder in which signs and symptoms are variable and include changes in perception, emotion, cognition, thinking, and behaviour.

Randomized Double Blind Controlled Trial of Lurasidone versus Risperidone in Schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011813
Enrollment
54
Registered
2018-02-09
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: F200- Paranoid schizophrenia Health Condition 2: null- Schizophrenia

Interventions

Intervention1: Lurasidone: 40mg hs for 3 days than 40mg BD for 8 weeks. Intervention2: Risperidone: 3mg hs for 3 days than 3mg BD for 8 weeks Control Intervention1: NA: NA

Sponsors

Department of Pharmacology and therapeutics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of Schizophrenia as per ICD-10, DCR, Patients aged between 18 to 50 years, Not on any antipsychotic for last three months, Total duration of illness less than one year, Availability of a reliable informant, Written informed consent from the patient/legally acceptable representative

Exclusion criteria

Exclusion criteria: Positive and Negative Syndrome Scale (PANSS) score 120, Presence of any other major psychiatric disorder, except nicotine dependence, Patients at risk for harm to self or others, Established treatment resistance for schizophrenia, Pregnant and lactating females, Clinical situations requiring drugs which are CYP 3A4/2D6 inhibitors or inducers, Clinical situations requiring alternative drugs or interventions eg injectable antipsychotics, ECTs, change of therapy etc., or worsening of symptoms, Patients having any major medical/surgical illness or any clinically significant abnormality in baseline investigations, Patient on any other concomitant drugs that might alter serum interleukin levels

Design outcomes

Primary

MeasureTime frame
positive and negative syndrome scale Schizophrenia Cognitive Rating scale UKU side effect profile Timepoint: baseline,4 and 8 weeks

Secondary

MeasureTime frame
Immunological test; IL-6 estimationTimepoint: baseline and 8 weeks

Countries

India

Contacts

Public ContactDr Unnati Saxena

King George Medical University, Lucknow

nischal.anuradha@gmail.com

Outcome results

None listed

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