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临床试验/NCT07446218
NCT07446218尚未招募不适用

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

University of Lahore2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
148
试验地点
2
主要终点
Body weight (kg)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Pharmacist monitoring and counseling to prevent or delay metabolic syndrome (Behavioral)

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.

结局指标

主要结局

Body weight (kg)

时间窗: 12 weeks

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

Body Mass Index (kg/m2)

时间窗: 12 weeks

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

Waist circumference (cm)

时间窗: 12 weeks

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

次要结局

  • Fasting blood glucose (mg/dl)(12 weeks)
  • Blood pressure (mmHg)(12 weeks)
  • Triglyceride levels ((mg/dL)(12 weeks)

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Usman Rashid Malik

Assistant Professor

University of Lahore

研究点 (2)

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