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Completed

NCT Number: NCT06500624

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Rawalpindi, Punjab Province, 00666, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Pizotifen

Drug

Each subject will be given 0.5mg pizotifen with 10-20mg escitalopram in patients with depressive disorder

Primary outcomes

  1. Improvement in the severity of the depressive disorder

    Time frame: 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. To score the PHQ-9, assign points for each answer: 0 for "Not at all," 1 for "Several days," 2 for "More than half the days," and 3 for "Nearly every day." Sum the points from all nine questions to get a total score, which can range from 0 to 27. The total score is then interpreted based on severity: 0-4 (No/Minimal Depression), 5-9 (Mild Depression), 10-14 (Moderate Depression), 15-19 (Moderately Severe Depression), and 20-27 (Severe Depression).

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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