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

NCT ID: NCT06500624

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2024-09-30

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.

Conditions

Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment group

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

Group Type: EXPERIMENTAL

Pizotifen

Intervention Type: DRUG

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

Interventions

Pizotifen

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bilal Iqbal, MBBS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

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Shin C, Jeon SW, Lee SH, Pae CU, Hong N, Lim HK, Patkar AA, Masand PS, An H, Han C. Efficacy and Safety of Escitalopram, Desvenlafaxine, and Vortioxetine in the Acute Treatment of Anxious Depression: A Randomized Rater-blinded 6-week Clinical Trial. Clin Psychopharmacol Neurosci. 2023 Feb 28;21(1):135-146. doi: 10.9758/cpn.2023.21.1.135.

Reference Type: BACKGROUND

PMID: 36700320 (View on PubMed)

Standal JE. Pizotifen as an antidepressant. Acta Psychiatr Scand. 1977 Oct;56(4):276-9. doi: 10.1111/j.1600-0447.1977.tb00228.x.

Reference Type: BACKGROUND

PMID: 335788 (View on PubMed)

Amoozegar F. Depression comorbidity in migraine. Int Rev Psychiatry. 2017 Oct;29(5):504-515. doi: 10.1080/09540261.2017.1326882. Epub 2017 Jul 6.

Reference Type: BACKGROUND

PMID: 28681617 (View on PubMed)

Power L, Shute W, McOwan B, Murray K, Szmulewicz D. Clinical characteristics and treatment choice in vestibular migraine. J Clin Neurosci. 2018 Jun;52:50-53. doi: 10.1016/j.jocn.2018.02.020. Epub 2018 Mar 14.

Reference Type: BACKGROUND

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Gaynes BN, Lux L, Gartlehner G, Asher G, Forman-Hoffman V, Green J, Boland E, Weber RP, Randolph C, Bann C, Coker-Schwimmer E, Viswanathan M, Lohr KN. Defining treatment-resistant depression. Depress Anxiety. 2020 Feb;37(2):134-145. doi: 10.1002/da.22968. Epub 2019 Oct 22.

Reference Type: BACKGROUND

PMID: 31638723 (View on PubMed)

Vigo DV, Kazdin AE, Sampson NA, Hwang I, Alonso J, Andrade LH, Ayinde O, Borges G, Bruffaerts R, Bunting B, de Girolamo G, Florescu S, Gureje O, Haro JM, Harris MG, Karam EG, Karam G, Kovess-Masfety V, Lee S, Navarro-Mateu F, Posada-Villa J, Scott K, Stagnaro JC, Have MT, Wu CS, Xavier M, Kessler RC. Determinants of effective treatment coverage for major depressive disorder in the WHO World Mental Health Surveys. Int J Ment Health Syst. 2022 Jun 23;16(1):29. doi: 10.1186/s13033-022-00539-6.

Reference Type: BACKGROUND

PMID: 35739598 (View on PubMed)

Other Identifiers

Riphah/IIMC/IRC/23/3113

Identifier Type: -

Identifier Source: org_study_id