Add-on Aripiprazole on Cardiometabolic Profile in Treatment Resistant Schizophrenia: RCT
Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar