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

Riphah International University

Status: Completed

Conditions: Depression

Treatments: Drug: Pizotifen

Study type: Interventional

Funder types: Other

Identifiers

NCT06500624

Riphah/IIMC/IRC/23/3113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

88 participants in 2 patient groups

Control group

No Intervention group

Description:

Each subject will be given 10-20mg Escitalopram with depressive disorder.

Treatment group

Experimental group

Description:

Each subject will be given 10-20mg of escitalopram with 0.5mg pizotifen with depressive disorder.

Treatment:

Drug: Pizotifen