Add-on Aripiprazole on Cardiometabolic Profile in Treatment Resistant Schizophrenia: RCT

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial participant population is to evaluate the effect of add on Aripiprazole in reducing the metabolic parameters in patients of TRS on Clozapine with metabolic syndrome. The cardiovascular risk would be measured by calculating the change in QRISK3(QRISK3 is an algorithm tool used to calculate cardiovascular risk. The software calculates the risk score using various parameters. It is a name not an abbreviation.) score and the metabolic parameters by change in Low density lipoprotein(LDL)/High-density lipoprotein(HDL) ratio, High sensitive C Reactive Protein (hs CRP), Insulin resistance (HOMA IR) and fasting plasma glucose level. The main question is to find out the change in cardiovascular risk score between the study groups in TRS on Clozapine with metabolic syndrome. It aims to answer the change in cardiovascular risk in terms of change in QRISK 3 score.

• Participants will be assessed for cardiovascular risk using QRISK 3 and entering the entering information like age, height, BMI, weight, Lipid profile, past history of angina, Chronic Kidney Disease (CKD), Migraine etc in the QRISK 3 algorithm.

• Subsequently they will be assessed using rating scales like Positive and negative symptom scale (PANSS) and Clinical Global Improvement (CGI) for positive and negative symptoms and clinical global improvement respectively.

• They will be randomized into 2 groups and one group will receive treatment as usual while the other group will receive Aripiprazole 10 mg/day along with treatment as usual.

• They will be reassessed at 3 time points like baseline, at 3 months and 6 months.

• Blood sample will be collected for hs CRP, lipid profile, Fasting Blood Sugar (FBS) at the baseline and after 6 months.

Researchers will compare both the groups to see if augmentation with Aripiprazole will reduce the metabolic risk or not.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Aripiprazole; Clozapine; Metformin

Criteria

Inclusion Criteria:

• • Patients clinically diagnosed with TRS (TRRIP consensus criteria) on Clozapine for more than 6 months.

• Patients with metabolic syndrome (NCEP ATP III Definition).

• Patients aged above 25 years of either sex.

• Patients/LAR giving voluntary written consent for participation in the study.

Exclusion Criteria:

• • Patient on combination of Clozapine with other antipsychotics.

• Patients with any contraindication for Metformin/Aripiprazole.

• History of psychoactive substance abuse or dependence.

• Co-morbid psychiatric, major medical or neurological disorders.

• History of organicity or significant head injury.

• Pregnant and breastfeeding females.