Comparative Efficacy of Escitalopram Monotherapy and Escitalopram in Adjuvant With Pizotifen in Depressive Disorder

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Drug: Pizotifen

• Registration Number: NCT06500624
• Lead Sponsor: Riphah International University

Brief Summary

To compare the efficacy of escitalopram monotherapy and combination with pizotifen in patients of major depressive disorder(MDD).The levels of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) at base level and during follow-up.

Detailed Description

This is an open-label study assessing the comparative efficacy of escitalopram monotherapy and combination with pizotifen in patients of major depressive disorder efficacy of antidepressants in combination therapy. The plan is to enroll 84 patients with depression based on the Patient Health Questionnaire (PHQ-9) score of 9 and above is a valid and reliable Structured Clinical Interview. The investigators will collect data from the enrolled patient populations. The participants will be able to receive their results, on request, upon completion of the study. The investigators hypothesize that depressive symptoms can be improved by the addition of the above-mentioned drug with antidepressant medication.

Study Timeline

• Study Start: 2024-06-03
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2024-08-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Newly diagnosed patients of Depressive Disorder (PHQ-9).6
• Males and female patients from age 14-70 years.
• The same drug brand will be used throughout the study period.

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Exclusion Criteria

• Schizophrenia, bipolar disease, active delirium, dementia.
• Pregnant and lactating females.
• History of renal and hepatic disease, myasthenia gravis, gastrointestinal (GI) disease, asthma, cardiovascular disease, and Diabetes Mellitus.
• Mentally handicapped or terminally ill patients.
• Age less than 14 years or above 70 years.
• Patients already taking multiple nutritional supplements.
• Patients taking medications known to interact with the drugs in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Pizotifen	Each subject will be given 10-20mg of escitalopram with 0.5mg pizotifen with depressive disorder.

Primary Outcome Measures

Name	Time	Method
Improvement in the severity of the depressive disorder	4 weeks	To find a difference in the clinical improvement of depressive symptoms in combination, by using Patient Health Questionnaire, PHQ-9, which is a self administered scale, in combination with pizotifen.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Rawalpindi, Punjab, Pakistan