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

NCT05766540 | Unknown Phase 4 DMC

• 1 other identifier: T/IM-F/21-22/30
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in QRISK3 score (QRISK3 is an algorythm based software which calculates the score using various parameters. It is not an abbreviation.).

  interpreted in terms of percentage. Score of more than 10 % would be considered as having risk of cardiovascular risk.

  6 months

Secondary Outcomes (6)

• Change in Low density lipoprotein (LDL)/High density lipoprotein (HDL) ratio.

  6 months

• Change in Insulin Resistance.

  6 months

• Change in Positive and negative symptom scale (PANSS) scores

  6 months

• Change in C reactive protein (CRP).

  6 months

• Change in Clinical Global Improovement for Schizophrenia (CGI-SCH) scores

  6 months

Study Arms (2)

Aripiprazole

EXPERIMENTAL

This group will receive Aripiprazole 10 mg/day for 6 months along with Clozapine and Metformin

Drug: Aripiprazole 10 MG

Treatment as usual

PLACEBO COMPARATOR

This group will receive Clozapine and Metformin.

Drug: Aripiprazole 10 MG

Interventions

Aripiprazole 10 MG DRUG

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

Also known as: Clozapine, Metformin 1000 mg

Aripiprazole; Treatment as usual

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Related Publications (6)

• Saha S, Chant D, McGrath J. A systematic review of mortality in schizophrenia: is the differential mortality gap worsening over time? Arch Gen Psychiatry. 2007 Oct;64(10):1123-31. doi: 10.1001/archpsyc.64.10.1123.

  PMID: 17909124 RESULT

• Mitchell AJ, Vancampfort D, Sweers K, van Winkel R, Yu W, De Hert M. Prevalence of metabolic syndrome and metabolic abnormalities in schizophrenia and related disorders--a systematic review and meta-analysis. Schizophr Bull. 2013 Mar;39(2):306-18. doi: 10.1093/schbul/sbr148. Epub 2011 Dec 29.

  PMID: 22207632 RESULT

• Boden R, Edman G, Reutfors J, Ostenson CG, Osby U. A comparison of cardiovascular risk factors for ten antipsychotic drugs in clinical practice. Neuropsychiatr Dis Treat. 2013;9:371-7. doi: 10.2147/NDT.S40554. Epub 2013 Mar 19.

  PMID: 23682213 RESULT

• Zimbron J, Khandaker GM, Toschi C, Jones PB, Fernandez-Egea E. A systematic review and meta-analysis of randomised controlled trials of treatments for clozapine-induced obesity and metabolic syndrome. Eur Neuropsychopharmacol. 2016 Sep;26(9):1353-1365. doi: 10.1016/j.euroneuro.2016.07.010. Epub 2016 Aug 2.

  PMID: 27496573 RESULT

• Choi YJ. Efficacy of adjunctive treatments added to olanzapine or clozapine for weight control in patients with schizophrenia: a systematic review and meta-analysis. ScientificWorldJournal. 2015;2015:970730. doi: 10.1155/2015/970730. Epub 2015 Jan 13.

  PMID: 25664341 RESULT

• Bai YM, Lin CC, Chen JY, Chen TT, Su TP, Chou P. Association of weight gain and metabolic syndrome in patients taking clozapine: an 8-year cohort study. J Clin Psychiatry. 2011 Jun;72(6):751-6. doi: 10.4088/JCP.09m05402yel. Epub 2010 Nov 30.

  PMID: 21208584 RESULT

MeSH Terms

Interventions

Aripiprazole; Clozapine; Metformin

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 13, 2023
• Study Start: August 20, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07