Mental DisordersNCT07446218
Pharmacist-led Interventions in Psychiatric Patients
A study testing Pharmacist monitoring and counseling to prevent or delay metabolic syndrome in people with Mental Disorders and Metabolic Syndrome, run by University of Lahore at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mental Disorders, Metabolic Syndrome
- What is being tested?
- Pharmacist monitoring and counseling to prevent or delay metabolic syndrome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Mar 2026to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Punjab Institute of Mental Health
Lahore, Punjab Province, 54000
Waqas Shabbir, Clinical Psychologist, +923315177898, shabbirwaqas1031@gmail.com
The University of Lahore
Lahore, Punjab Province, 54000
Usman R Malik, PhD, +923096840007, usman.rashid@pharm.uol.edu.pk
Sundas Anees, Pharm.D, +923345517671, 70178033@student.uol.edu.pk
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Disorders, Metabolic Syndrome
- Being tested
- Pharmacist monitoring and counseling to prevent or delay metabolic syndrome
- Keywords
- severe mental illness, chronic mental disorder, atypical antipsychotics, intervention study, RCT, Pakistan, metabolic syndrome, second generation antipsychotics, educational intervention
- Medical subject headings
- Mental Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist monitoring and counseling to prevent or delay metabolic syndromeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Change in body weight (kg) from baseline to 12 weeks
Measured: 12 weeks
Body Mass Index (kg/m2)
Change in Body Mass Index (kg/m2) from baseline to 12 weeks
Measured: 12 weeks
Waist circumference (cm)
Change in waist circumference (cm) from baseline to 12 weeks
Measured: 12 weeks
Secondary outcomes (3)
Fasting blood glucose (mg/dl)
Change in fasting blood glucose (mg/dl) from baseline to 12 weeks
Measured: 12 weeks
Blood pressure (mmHg)
Change in blood pressure (mmHg) from baseline to 12 weeks
Measured: 12 weeks
Triglyceride levels ((mg/dL)
Measurement of the change in fasting serum triglyceride concentrations from baseline to 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Punjab Institute of Mental Health
- Responsible party
- Principal investigator, Usman Rashid Malik, University of Lahore
- Investigators
- Usman R Malik, PhD, Principal investigator, Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446218
- Sponsor's protocol ID
- DREC-2025-09H
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 34560826Maurus 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.
PubMed 39655999Luciano 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.
PubMed 37665401Kelebie 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.
PubMed 40301830Johnson 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.
PubMed 38180874Fang 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.
PubMed 39472855Bui 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.
PubMed 39154118Beyene 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.
PubMed 39391415Alvi 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.
PubMed 37531228Ali 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.
PubMed 37755643Al 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.
PubMed 32607719Abdulhaq 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.
PubMed 33156542
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmacist-Led Interventions in Psychiatric Patients on Second Generation Antipsychotics
- ClinicalTrials.gov ID
- NCT07446218
- Acronym / sponsor ID
- DREC-2025-09H
- Conditions
- Mental Disorders, Metabolic Syndrome
- Keywords
- severe mental illness, chronic mental disorder, atypical antipsychotics, intervention study, RCT, Pakistan, metabolic syndrome, second generation antipsychotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- Punjab Institute of Mental Health
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Pharmacist monitoring and counseling to prevent or delay metabolic syndromeParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist monitoring and counseling to prevent or delay metabolic syndromePatients 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 | Behavioural | Intervention Group |
Primary outcome
Body weight (kg)
Time frame: 12 weeks
Change in body weight (kg) from baseline to 12 weeks
Body Mass Index (kg/m2)
Time frame: 12 weeks
Change in Body Mass Index (kg/m2) from baseline to 12 weeks
Waist circumference (cm)
Time frame: 12 weeks
Change in waist circumference (cm) from baseline to 12 weeks
3 secondary outcomes
Fasting blood glucose (mg/dl)
Time frame: 12 weeks
Blood pressure (mmHg)
Time frame: 12 weeks
Triglyceride levels ((mg/dL)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 34560826Ng 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.
- Background: PubMed 39655999Maurus 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.
- Background: PubMed 37665401Luciano 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.
- Background: PubMed 40301830Kelebie 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.
- Background: PubMed 38180874Johnson 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.
- Background: PubMed 39472855Fang 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.
- Background: PubMed 39154118Bui 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.
- Background: PubMed 39391415Beyene 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.
- Background: PubMed 37531228Alvi 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.
- Background: PubMed 37755643Ali 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.
- Background: PubMed 32607719Al 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.
- Background: PubMed 33156542Abdulhaq 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.
- Mental health care: A handbook for pharmacists (2022)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Usman R Malik, PhD principal investigator
Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist monitoring and counseling to prevent or delay metabolic syndrome in people with Mental Disorders and Metabolic Syndrome, run by University of Lahore at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Usman R Malik, PhD (+923096840007, usman.rashid@pharm.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07446218, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.