Health TrialsbyHealthPanel

Pharmacist-led Interventions in Psychiatric Patients

ConditionsMental DisordersMetabolic Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with severe medical comorbidities.

Pregnant or breastfeeding women.

Patients receiving only first-generation antipsychotics.

Patients taking more than three antipsychotics.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Body weight (kg)

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

Time frame
12 weeks
2

Body Mass Index (kg/m2)

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

Time frame
12 weeks
3

Waist circumference (cm)

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

Time frame
12 weeks

Secondary outcomes

1

Fasting blood glucose (mg/dl)

Change in fasting blood glucose (mg/dl) from baseline to 12 weeks

Time frame
12 weeks
2

Blood pressure (mmHg)

Change in blood pressure (mmHg) from baseline to 12 weeks

Time frame
12 weeks
3

Triglyceride levels ((mg/dL)

Measurement of the change in fasting serum triglyceride concentrations from baseline to 12 weeks

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Lahore

Lead sponsor

Punjab Institute of Mental Health

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: