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

Completed

• Conditions: Schizophrenia,

• Registration Number: CTRI/2022/04/041843
• Lead Sponsor: Alok Gupta

Brief Summary

This study is a randomized, single blind, parallel group, single-centre trial comparing the effectiveness and cardio metabolic safety of Lurasidone and olanzapine for 12 months in 120 patients with Schizophrenia that will be conducted in India. The primary outcome measures will be Positive andNegative Syndrome Scale, Brief Psychiatric Rating Scale and ClinicalGlobal Impressions Scale – Impressions at 6 weeks. The secondary outcomes will be LipidProfile, Fasting Blood Sugar, Post Prandial Blood Sugar and ECGat 6 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-17
• Study Completion: 2022-10-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale, Clinical Global Impressions Scale – Impressions and Montreal Cognitive Assessment would be used to assess change in symptoms of Schizophrenia.	At the time of enrollment in the study and at the end of 6 weeks.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IMS SUM Hospital; 🇮🇳 Khordha, ORISSA, India

IMS SUM Hospital

🇮🇳Khordha, ORISSA, India

Alok Gupta

Principal investigator

8840236928

dralokgupta90@yahoo.com