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

NCT06500624 | Completed

• 1 other identifier: Riphah/IIMC/IRC/23/3113
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Improvement in the severity of the depressive disorder

  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).

  4 weeks

Study Arms (2)

Control group

NO INTERVENTION

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

Treatment group

EXPERIMENTAL

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

Drug: Pizotifen

Interventions

Pizotifen DRUG

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Rawalpindi, Punjab Province, 00666, Pakistan

Location

Related Publications (7)

• Zhang Q, Shao A, Jiang Z, Tsai H, Liu W. The exploration of mechanisms of comorbidity between migraine and depression. J Cell Mol Med. 2019 Jul;23(7):4505-4513. doi: 10.1111/jcmm.14390. Epub 2019 May 20.

  PMID: 31106971 BACKGROUND

• 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.

  PMID: 36700320 BACKGROUND

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

  PMID: 335788 BACKGROUND

• 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.

  PMID: 28681617 BACKGROUND

• 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.

  PMID: 29550250 BACKGROUND

• 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.

  PMID: 31638723 BACKGROUND

• 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.

  PMID: 35739598 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Pizotyline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bilal Iqbal, MBBS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: June 3, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)