Pharmacist-led Interventions in Psychiatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacist monitoring and counseling to prevent or delay metabolic syndrome.
- Who it may be relevant to
- Registry conditions: Mental Disorders, Metabolic Syndrome. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Pharmacist-Led Interventions in Psychiatric Patients on Second Generation Antipsychotics
Overview
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
- 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 circumferen
Primary outcome measures
- Body weight (kg) [Time frame: 12 weeks]
- Body Mass Index (kg/m2) [Time frame: 12 weeks]
- Waist circumference (cm) [Time frame: 12 weeks]
Secondary outcome measures (3)
- Fasting blood glucose (mg/dl) [Time frame: 12 weeks]
- Blood pressure (mmHg) [Time frame: 12 weeks]
- Triglyceride levels ((mg/dL) [Time frame: 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Pakistan · 2 centers
- Punjab Institute of Mental Health — Lahore
- The University of Lahore — Lahore
Publications
- 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
- 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
- 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 C PMID 37665401
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07446218 · DREC-2025-09H