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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pizotifen | Drug | Each subject will be given 0.5mg pizotifen with 10-20mg escitalopram in patients with depressive disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bilal Iqbal, MBBS | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riphah International University | Rawalpindi | Punjab Province | 00666 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31106971 | Background | 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. | |
| 36700320 | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010918 | Pizotyline |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 335788 | 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. |
| 28681617 | 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. |
| 29550250 | 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. |
| 31638723 | 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. |
| 35739598 | 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. |
| D006571 |
| Heterocyclic Compounds |