A STUDY TO COMPARE THE WEIGHT, BLOOD SUGAR AND FAT CHANGES IN PATIENTS ON TREATMENT WITH OLANZAPINE, RISPERIDONE AND QUETIAPINE.

Not yet recruiting

Conditions: Mental, Behavioral and Neurodevelopmental disorders,

Registration Number: CTRI/2019/05/019447

Lead Sponsor: Father Muller Medical College Hospital

Brief Summary: **OBJECTIVES OF THE STUDY:**

To study the adverse effects on metabolic parameters in patients receiving treatment with either Olanzapine or Quetiapine or Risperidone.

**NEED FOR THE STUDY:** Head to head Comparison of  Metabolic disturbance induced by Olanzapine, risperidone and quetiapine is a little researched domain and there is a distinct lack of information in this aspect, particularly in Indian subjects. There is a need to look into the association of dose and duration of treatment with study drugs and the risk of developing metabolic adverse drug effects, so as to intervene at that point to prevent unfavorable outcome. As early onset diabetes and associated cardiometabolic complications are on the rise in general population in India, it is pertinent to study the occurrence of metabolic abnormalities like hyperglycemia, dyslipidemia and obesity in patients on monotherapy with study drugs  thus contributing to the appropriate drug choices these patients requiring antipsychotic therapy.

**MATERIAL AND METHODS**

**STUDY TYPE:** Observational, hospital based study.

**SOURCE OF DATA:**Inpatients and Outpatients attending the Department of Psychiatry , Father Muller Medical College Hospital , Mangalore will be screened for inclusion based on the criteria given below.

**SELECTION CRITERIA**

**Inclusion criteria:**

Â·       Patients taking antipsychotic treatment with any one of the drugs: Olanzapine, Risperidone, Quetiapine, for a minimum period of 6 months to a maximum period of 1 year.

Â·       Patients of either gender aged between 20-65 yrs.

**Exclusion criteria:**

Â·       Not on monotherapy with study drugs

Â·       Patient is a known case of diabetes or dyslipidemia or has a Pretreatment history of diabetes or dyslipidemia.

Â·       Patients on Lithium, Nortriptyline, Amitriptyline, valproic acid, antidepressants for past 3 months and other psychotropic agents known to affect insulin sensitivity.

Â·       Those on other non-psychiatric drugs known to cause weight gain, hyperglycemia or dyslipidemia like steroids, diuretics, hyperglycemia producing antiepileptics.

Â·       Have current substance abuse or dependency disorder.

Â·       Pregnancy

Â·       Any clinically relevant disease (liver, renal or heart disease).

**METHOD OF COLLECTION OF DATA**

This is a cross-sectional, observational study in which patients taking antipsychotic treatment prescribed to them by their treating psychiatrist, for a minimum period of 6 months to a maximum period of 1 year and fulfilling the above mentioned criteria will be recruited for the study. A written informed consent will be taken before proceeding to assess the metabolic parameters. Baseline data like psychiatric diagnosis, height, weight and blood pressure before the initiation of therapy, prescribed drugs, dose and duration of treatment with the study drugs will be taken from case records. A detailed patient history will be taken covering the following categories: Patient details, Clinical history, family and personal history, treatment information including current antipsychotic, dose and duration of treatment, previous anti-psychotic treatment, will be collected. Clinical examination for signs of insulin resistance , dyslipidemia, vitals like blood pressure and anthropometric measurements like weight, height, BMI will be obtained from all participants . The subjects will then be assessed for the present analyses which includes laboratory investigations like fasting blood samples for plasma glucose , whole blood glycated HbA1c, Serum Triglycerides and serum HDL. All the blood tests will be done according to the same standardized procedures of Father Muller Medical Hospital , Mangalore laboratory. All the details obtained will then be entered into a predesigned Proforma and analyzed statistically.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 86

Inclusion Criteria

Patients taking antipsychotic treatment with any one of the drugs: Olanzapine, Risperidone, Quetiapine, for a minimum period of 6 months to a maximum period of 1 year.

Exclusion Criteria

Not on monotherapy with study drugs Patient is a known case of diabetes or dyslipidemia or has a Pretreatment history of diabetes or dyslipidemia.
Patients on Lithium, Nortriptyline, Amitriptyline, valproic acid, antidepressants for past 3 months and other psychotropic agents known to affect insulin sensitivity.
Those on other non-psychiatric drugs known to cause weight gain, hyperglycemia or dyslipidemia like steroids, diuretics, hyperglycemia producing antiepileptics.
Have current substance abuse or dependency disorder.Pregnancy.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the adverse effects on metabolic parameters like weight change from baseline, blood glucose level change and triglyceride level change from normal in patients not previously known to have metabolic abnormalities, receiving treatment with either Olanzapine or Quetiapine or Risperidone.	Patients will be assessed at that time point when on treatment with the study drugs for a duration of 6 months to 1 year.

Secondary Outcome Measures

Name	Time	Method
To assess the Blood pressure change from baseline in patients receiving treatment with olanzapine or risperidone or quetiapine.	Patients will be assessed at that time point when on treatment with the study drugs for a duration of 6 months to 1 year.

Trial Locations

Locations (1): Father Muller Medical Hospital
🇮🇳
Kannada, KARNATAKA, India
Father Muller Medical Hospital
🇮🇳Kannada, KARNATAKA, India
Dr Quadros Reshma Ronald
Principal investigator
9620792441
reshmaquadros.rq@gmail.com