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NCT Number: NCT07446218

Pharmacist-led Interventions in Psychiatric Patients

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Punjab Institute of Mental Health, Lahore, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacist monitoring and counseling to prevent or delay metabolic syndrome

Behavioral

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

Primary outcomes

  1. Body weight (kg)

    Time frame: 12 weeks

    Change in body weight (kg) from baseline to 12 weeks

  2. Body Mass Index (kg/m2)

    Time frame: 12 weeks

    Change in Body Mass Index (kg/m2) from baseline to 12 weeks

  3. Waist circumference (cm)

    Time frame: 12 weeks

    Change in waist circumference (cm) from baseline to 12 weeks

Secondary outcomes

  1. Fasting blood glucose (mg/dl)

    Time frame: 12 weeks

    Change in fasting blood glucose (mg/dl) from baseline to 12 weeks

  2. Blood pressure (mmHg)

    Time frame: 12 weeks

    Change in blood pressure (mmHg) from baseline to 12 weeks

  3. Triglyceride levels ((mg/dL)

    Time frame: 12 weeks

    Measurement of the change in fasting serum triglyceride concentrations from baseline to 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sundas Anees, Pharm.D

CONTACT

[email protected]

+923345517671

Usman R Malik, PhD

CONTACT

[email protected]

+923096840007

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Collaborators

  • Punjab Institute of Mental Health

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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