Pharmacist-led Interventions in Psychiatric Patients

NCT07446218 | Not Yet Recruiting

• 1 other identifier: DREC-2025-09H
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Disorders; Metabolic Syndrome

Keywords

severe mental illness; chronic mental disorder; atypical antipsychotics; intervention study; RCT; Pakistan; metabolic syndrome; second generation antipsychotics; educational intervention

Outcome Measures

Primary Outcomes (3)

• Body weight (kg)

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

  12 weeks

• Body Mass Index (kg/m2)

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

  12 weeks

• Waist circumference (cm)

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

  12 weeks

Secondary Outcomes (3)

• Fasting blood glucose (mg/dl)

  12 weeks

• Blood pressure (mmHg)

  12 weeks

• Triglyceride levels ((mg/dL)

  12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Punjab Institute of Mental Health: collaborator
• University of Lahore: lead

Study Sites (2)

Punjab Institute of Mental Health

Lahore, Punjab Province, 54000, Pakistan

Location

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (12)

• Ng R, El-Den S, Stewart V, Collins JC, Roennfeldt H, McMillan SS, Wheeler AJ, O'Reilly CL. Pharmacist-led interventions for people living with severe and persistent mental illness: A systematic review. Aust N Z J Psychiatry. 2022 Sep;56(9):1080-1103. doi: 10.1177/00048674211048410. Epub 2021 Sep 24.

  PMID: 34560826 BACKGROUND

• Maurus I, Wagner S, Spaeth J, Vogel A, Muenz S, Seitz V, von Philipsborn P, Solmi M, Firth J, Stubbs B, Vancampfort D, Hallgren M, Kurimay T, Gerber M, Correll CU, Gaebel W, Moller HJ, Schmitt A, Hasan A, Falkai P. EPA guidance on lifestyle interventions for adults with severe mental illness: A meta-review of the evidence. Eur Psychiatry. 2024 Dec 10;67(1):e80. doi: 10.1192/j.eurpsy.2024.1766.

  PMID: 39655999 BACKGROUND

• Luciano M, Sampogna G, D'Ambrosio E, Rampino A, Amore M, Calcagno P, Rossi A, Rossi R, Carmassi C, Dell'Osso L, Bianciardi E, Siracusano A, Della Rocca B, Di Vincenzo M; LIFESTYLE Working Group; Fiorillo A. One-year efficacy of a lifestyle behavioural intervention on physical and mental health in people with severe mental disorders: results from a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2024 Jun;274(4):903-915. doi: 10.1007/s00406-023-01684-w. Epub 2023 Sep 4.

  PMID: 37665401 BACKGROUND

• Kelebie M, Kibralew G, Tadesse G, Nakie G, Ali D, Fanta B, Muche M, Fentahun S, Rtbey G, Takelle GM. Prevalence and predictors of metabolic syndrome among psychiatric patients receiving antipsychotic treatment in Africa: a systematic review and meta-analysis. BMC Psychiatry. 2025 Apr 29;25(1):433. doi: 10.1186/s12888-025-06894-1.

  PMID: 40301830 BACKGROUND

• Johnson CF, Ingram F, Thomson F, Srireddy P, Jani BD, Greenlaw N. General practice pharmacist-led antipsychotic physical health monitoring: a prospective intervention scoping study. Fam Pract. 2024 Feb 28;41(1):41-49. doi: 10.1093/fampra/cmad120.

  PMID: 38180874 BACKGROUND

• Fang YJ, Lee WY, Lin CL, Cheah YC, Hsieh HH, Chen CH, Tsai FJ, Tien N, Lim YP. Association of antipsychotic drugs on type 2 diabetes mellitus risk in patients with schizophrenia: a population-based cohort and in vitro glucose homeostasis-related gene expression study. BMC Psychiatry. 2024 Oct 30;24(1):751. doi: 10.1186/s12888-024-06222-z.

  PMID: 39472855 BACKGROUND

• Bui TNT, Au RT, Janetzki JL, McMillan SS, Hotham E, Suppiah V. Metabolic Monitoring for Adults Living with a Serious Mental Illness on a Second-Generation Antipsychotic Agent: A Scoping Review. Adm Policy Ment Health. 2025 Mar;52(2):289-317. doi: 10.1007/s10488-024-01408-9. Epub 2024 Aug 17.

  PMID: 39154118 BACKGROUND

• Beyene MG, Teferra S, Fenta TG. Metabolic Syndrome and Its Associated Factors Among Patients With Schizophrenia Treated With Second-Generation Antipsychotics at Amanuel Mental Specialized Hospital, Ethiopia. Cureus. 2024 Sep 10;16(9):e69065. doi: 10.7759/cureus.69065. eCollection 2024 Sep.

  PMID: 39391415 BACKGROUND

• Alvi MH, Ashraf T, Kiran T, Iqbal N, Gumber A, Patel A, Husain N. Economic burden of mental illness in Pakistan: an estimation for the year 2020 from existing evidence. BJPsych Int. 2023 Aug;20(3):54-56. doi: 10.1192/bji.2023.4.

  PMID: 37531228 BACKGROUND

• Ali RA, Jalal Z, Johal J, Paudyal V. Guideline adherence for cardiometabolic monitoring of patients prescribed antipsychotic medications in primary care: a retrospective observational study. Int J Clin Pharm. 2023 Oct;45(5):1241-1251. doi: 10.1007/s11096-023-01642-5. Epub 2023 Sep 27.

  PMID: 37755643 BACKGROUND

• Al AdAwi RM, Stewart D, Ryan C, Tonna AP. A systematic review of pharmacist input to metabolic syndrome screening, management and prevention. Int J Clin Pharm. 2020 Aug;42(4):995-1015. doi: 10.1007/s11096-020-01084-3. Epub 2020 Jun 30.

  PMID: 32607719 BACKGROUND

• Abdulhaq B, Dardas LA, Sami O. Monitoring for the metabolic side effects of second-generation antipsychotic medications: Psychiatrists' views and practices. Perspect Psychiatr Care. 2021 Jul;57(3):1237-1243. doi: 10.1111/ppc.12679. Epub 2020 Nov 6.

  PMID: 33156542 BACKGROUND

Related Links

• Mental health care: A handbook for pharmacists (2022)

MeSH Terms

Conditions

Mental Disorders; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Usman R Malik, PhD

  Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Usman R Malik, PhD

CONTACT

+923096840007; usman.rashid@pharm.uol.edu.pk

Sundas Anees, Pharm.D

CONTACT

+923345517671; 70178033@student.uol.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

PA (2)