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

NCT05766540 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-20

No results posted yet for this study

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.

Conditions

  • Difference in the Change in Cardiovascular Risk in Treatment Resistant Schizophrenia

Interventions

DRUG

Aripiprazole 10 MG

Aripiprazole hroup will receive Aripiprazole 10 mg/day along with Clozapine and Metformin

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2023-11-30
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766540 on ClinicalTrials.gov