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A clinical trial to study the effects and safety of two drugs, Lurasidone and olanzapine in patients with Schizophrenia

A comparative study to assess the effectiveness and cardio-metabolic safety profile of Lurasidone versus Olanzapine in patients with Schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041843
Enrollment
120
Registered
2022-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Lurasidone: 40mg-160mg, once daily dosage and oral intake for 6 weeks. Control Intervention1: Olanzapine: 5mg-20mg, once daily dosage, oral intake for 6 weeks.

Sponsors

Alok Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients giving informed consent, diagnosed with Schizophrenia as per ICD 10 diagnostic criteria and drug free for atleast 8 weeks.

Exclusion criteria

Exclusion criteria: Known case of diabetes mellitus, dyslipidemia and cardiac illness. Systemic or neurological Disorder affecting cognition, behavior or mental status. Substance dependence except nicotine and caffeine within the past month of entering the study.Long standing medical or surgical illness and patients with mental retardation or organic brain disease.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale, Clinical Global Impressions Scale â?? Impressions and Montreal Cognitive Assessment would be used to assess change in symptoms of Schizophrenia.Timepoint: At the time of enrollment in the study and at the end of 6 weeks.

Secondary

MeasureTime frame
Lipid Profile, Fasting Blood Sugar, Post Postprandial Blood Sugar and ECG would be done to assess change in cardio metabolic parameters in the patients.Timepoint: At the time of enrollment in the study and at the end of 6 weeks.

Countries

India

Contacts

Public ContactAlok Gupta

IMS SUM Hospital

dr.sar07@gmail.com9861273580

Outcome results

None listed

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