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

Last updated: July 8, 2024
Sponsor: Riphah International University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Pizotifen

Clinical Study ID

NCT06500624
Riphah/IIMC/IRC/23/3113
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Exclusion

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.

Study Design

Total Participants: 88
Treatment Group(s): 1
Primary Treatment: Pizotifen
Phase:
Study Start date:
June 03, 2024
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Riphah International University

    Rawalpindi, Punjab 00666
    Pakistan

    Active - Recruiting

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