Mental Disorders, Metabolic Syndrome
Conditions
Keywords
severe mental illness, chronic mental disorder, atypical antipsychotics, intervention study, RCT, Pakistan, metabolic syndrome, second generation antipsychotics, educational intervention
Brief summary
The goal of this intervention study is to examine the impact of pharmacist-led interventions in psychiatric patients initiating second-generation antipsychotic treatment. The primary purpose is to assess the impact of intervention on antipsychotic induced metabolic outcomes, such as weight gain and other cardiometabolic risk markers, in patients aged 18 to 60 years who have been diagnosed with chronic mental disorder. Participants will be assigned to either the intervention or the control group. The intervention group will receive educational interventions from the pharmacist at baseline, after 4 weeks, 8 weeks, and 12 weeks along with the standard therapy prescribed by the psychiatrist. On the other hand, the control group will receive only the standard therapy with no intervention from the pharmacist.
Detailed description
Severe Mental Disorders (SMD) need long-term treatment with second-generation antipsychotics (SGAs). These disorders include schizophrenia, bipolar disorder, and major depression. Second-generation antipsychotics can control negative symptoms effectively as compared to first-generation antipsychotics. But they can cause metabolic effects such as weight gain, high cholesterol, and irregular blood sugar levels, which can lead to metabolic syndrome. Through pharmacist-led interventions, this study aims to see metabolic outcomes in those patients who are taking second-generation antipsychotics. International guidelines emphasize regular monitoring of these patients and their metabolic parameters and recommend appropriate lifestyle interventions. Adherence to these guidelines is often poor in many countries, including Pakistan. Pharmacists are essential members of multidisciplinary care teams. They can help to improve monitoring, counsel patients, and detect metabolic complications early. Despite this, their role in psychiatric care in Pakistan is still limited. To address this gap, the investigators will evaluate the impact of a pharmacist-led metabolic monitoring program combined with guidance on medication use and lifestyle interventions for patients on second-generation antipsychotics. This will be a single-center controlled interventional study conducted in psychiatric care settings. Eligible patients on long-term second-generation antipsychotics will be assigned to the intervention or control group using a predefined allocation method. The intervention group will receive monitoring of weight, waist circumference, blood pressure, fasting glucose, and lipid profile alongwith guidance on medication use and personalized lifestyle counseling. The control group will receive only standard care according to hospital protocols. Data will be collected at the start and after 12 weeks. Metabolic outcomes and the effectiveness of pharmacist-led services will be analyzed. The investigators expect the intervention to reduce antipsychotic-related weight gain, improve lipid and glucose profiles, and further avoid life-threatening complications. This study will provide high-quality, locally relevant evidence. It aims to show that pharmacist involvement is feasible and can make antipsychotic treatment safer and more effective in Pakistan.
Interventions
BEHAVIORALPharmacist monitoring and counseling to prevent or delay metabolic syndrome
Patients will have a 20-30 minutes meetings with a clinical pharmacist at baseline, week 4, 8, and 12. Pharmacist will do metabolic assessments at each visit and individually counsel the patient on diet, physical activity and weight management. He will educate the patient on medication use, metabolic syndrome, cardiovascular risk and weight gain due to second generation antipsychotics. Clinical Pharmacist will assess the following parameters: * Weight * Body mass index (BMI) * Waist circumference * Blood pressure * Fasting blood glucose * Lipid profile
Sponsors
University of Lahore
Punjab Institute of Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-60 years. * Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder. * Currently prescribed a second-generation antipsychotic for \< 2 months. * Willing to participate in lifestyle and counseling sessions.
Exclusion criteria
* Patients with severe medical comorbidities. * Pregnant or breastfeeding women. * Patients receiving only first-generation antipsychotics. * Patients taking more than three antipsychotics. * Patients using combination of first and second generation antipsychotics. * Individuals with cognitive impairment. * Patients with type 2 diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight (kg) | 12 weeks | Change in body weight (kg) from baseline to 12 weeks |
| Body Mass Index (kg/m2) | 12 weeks | Change in Body Mass Index (kg/m2) from baseline to 12 weeks |
| Waist circumference (cm) | 12 weeks | Change in waist circumference (cm) from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose (mg/dl) | 12 weeks | Change in fasting blood glucose (mg/dl) from baseline to 12 weeks |
| Blood pressure (mmHg) | 12 weeks | Change in blood pressure (mmHg) from baseline to 12 weeks |
| Triglyceride levels ((mg/dL) | 12 weeks | Measurement of the change in fasting serum triglyceride concentrations from baseline to 12 weeks |
Countries
Pakistan
Contacts
CONTACTUsman R Malik, PhD
CONTACTSundas Anees, Pharm.D
PRINCIPAL_INVESTIGATORUsman R Malik, PhD
Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan
Outcome results
None listed