Pharmacist-led Interventions in Psychiatric Patients

February 25, 2026 updated by: Usman Rashid Malik, University of Lahore

Impact of Pharmacist-Led Interventions in Psychiatric Patients on Second Generation Antipsychotics

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • The University of Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Usman R Malik, PhD
        • Sub-Investigator:
          • Sundas Anees, Pharm.D
      • Lahore, Punjab Province, Pakistan, 54000
        • Punjab Institute of Mental Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants will receive prescribed therapy review, routine medical checkups and access to nursing support. In addition, they will receive pharmacist-led monitoring of weight, waist circumference, blood pressure, fasting glucose, and lipid profile. They will also receive guidance on medication use and personalized lifestyle counseling.
Behavioral: Pharmacist 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
No Intervention: Control Group
Participants will only receive prescribed therapy review, routine medical checkups and access to nursing support. They will not receive structured pharmacist-led monitoring or lifestyle counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight (kg)
Time Frame: 12 weeks
Change in body weight (kg) from baseline to 12 weeks
12 weeks
Body Mass Index (kg/m2)
Time Frame: 12 weeks
Change in Body Mass Index (kg/m2) from baseline to 12 weeks
12 weeks
Waist circumference (cm)
Time Frame: 12 weeks
Change in waist circumference (cm) from baseline to 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose (mg/dl)
Time Frame: 12 weeks
Change in fasting blood glucose (mg/dl) from baseline to 12 weeks
12 weeks
Blood pressure (mmHg)
Time Frame: 12 weeks
Change in blood pressure (mmHg) from baseline to 12 weeks
12 weeks
Triglyceride levels ((mg/dL)
Time Frame: 12 weeks
Measurement of the change in fasting serum triglyceride concentrations from baseline to 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Collaborators

Punjab Institute of Mental Health

Investigators

  • Principal Investigator: Usman R Malik, PhD, Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DREC-2025-09H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Since the study will involve psychiatric patients and sensitive health data, the plan to share particpant data with other researchers is still undecided. Also, there can be a risk of participant re-identification and some hospitals have strict data governance policies that prevent raw clinical data to be shared with individuals not directly invloved in the research project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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