Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:29 PM
Study NCT ID:
NCT07446218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacist-led Interventions in Psychiatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight (kg)', 'timeFrame': '12 weeks', 'description': 'Change in body weight (kg) from baseline to 12 weeks'}, {'measure': 'Body Mass Index (kg/m2)', 'timeFrame': '12 weeks', 'description': 'Change in Body Mass Index (kg/m2) from baseline to 12 weeks'}, {'measure': 'Waist circumference (cm)', 'timeFrame': '12 weeks', 'description': 'Change in waist circumference (cm) from baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose (mg/dl)', 'timeFrame': '12 weeks', 'description': 'Change in fasting blood glucose (mg/dl) from baseline to 12 weeks'}, {'measure': 'Blood pressure (mmHg)', 'timeFrame': '12 weeks', 'description': 'Change in blood pressure (mmHg) from baseline to 12 weeks'}, {'measure': 'Triglyceride levels ((mg/dL)', 'timeFrame': '12 weeks', 'description': 'Measurement of the change in fasting serum triglyceride concentrations from baseline to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe mental illness', 'chronic mental disorder', 'atypical antipsychotics', 'intervention study', 'RCT', 'Pakistan', 'metabolic syndrome', 'second generation antipsychotics', 'educational intervention'], 'conditions': ['Mental Disorders', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '34560826', 'type': 'BACKGROUND', 'citation': "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': '39655999', 'type': 'BACKGROUND', 'citation': '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': '37665401', 'type': 'BACKGROUND', 'citation': "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': '40301830', 'type': 'BACKGROUND', 'citation': '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': '38180874', 'type': 'BACKGROUND', 'citation': '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': '39472855', 'type': 'BACKGROUND', 'citation': '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': '39154118', 'type': 'BACKGROUND', 'citation': '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': '39391415', 'type': 'BACKGROUND', 'citation': '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': '37531228', 'type': 'BACKGROUND', 'citation': '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': '37755643', 'type': 'BACKGROUND', 'citation': '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': '32607719', 'type': 'BACKGROUND', 'citation': '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': '33156542', 'type': 'BACKGROUND', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'https://ncd.fip.org/publications/mental-health-handbook/', 'label': 'Mental health care: A handbook for pharmacists (2022)'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-60 years.\n* Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder.\n* Currently prescribed a second-generation antipsychotic for \\< 2 months.\n* Willing to participate in lifestyle and counseling sessions.\n\nExclusion Criteria:\n\n* Patients with severe medical comorbidities.\n* Pregnant or breastfeeding women.\n* Patients receiving only first-generation antipsychotics.\n* Patients taking more than three antipsychotics.\n* Patients using combination of first and second generation antipsychotics.\n* Individuals with cognitive impairment.\n* Patients with type 2 diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT07446218', 'briefTitle': 'Pharmacist-led Interventions in Psychiatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Impact of Pharmacist-Led Interventions in Psychiatric Patients on Second Generation Antipsychotics', 'orgStudyIdInfo': {'id': 'DREC-2025-09H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '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.', 'interventionNames': ['Behavioral: Pharmacist monitoring and counseling to prevent or delay metabolic syndrome']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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': [{'name': 'Pharmacist monitoring and counseling to prevent or delay metabolic syndrome', 'type': 'BEHAVIORAL', 'description': '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:\n\n* Weight\n* Body mass index (BMI)\n* Waist circumference\n* Blood pressure\n* Fasting blood glucose\n* Lipid profile', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Waqas Shabbir, Clinical Psychologist', 'role': 'CONTACT', 'email': 'shabbirwaqas1031@gmail.com', 'phone': '+923315177898'}], 'facility': 'Punjab Institute of Mental Health', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Usman R Malik, PhD', 'role': 'CONTACT', 'email': 'usman.rashid@pharm.uol.edu.pk', 'phone': '+923096840007'}, {'name': 'Sundas Anees, Pharm.D', 'role': 'CONTACT', 'email': '70178033@student.uol.edu.pk', 'phone': '+923345517671'}, {'name': 'Usman R Malik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sundas Anees, Pharm.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The University of Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Usman R Malik, PhD', 'role': 'CONTACT', 'email': 'usman.rashid@pharm.uol.edu.pk', 'phone': '+923096840007'}, {'name': 'Sundas Anees, Pharm.D', 'role': 'CONTACT', 'email': '70178033@student.uol.edu.pk', 'phone': '+923345517671'}], 'overallOfficials': [{'name': 'Usman R Malik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Punjab Institute of Mental Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Usman Rashid Malik', 'investigatorAffiliation': 'University of Lahore'}}}}