Comparing escitalopram alone versus with pizotifen for depression treatment
Comparative Efficacy of Escitalopram Monotherapy and Escitalopram in Adjuvant With Pizotifen in Depressive Disorder
This study is testing if adding pizotifen to the depression medication escitalopram helps people with major depressive disorder feel better compared to taking escitalopram alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Rawalpindi, Punjab) |
| Trial ID | NCT06500624 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of escitalopram monotherapy against its combination with pizotifen in treating major depressive disorder (MDD). It will enroll 84 patients who meet specific criteria based on their depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9). Participants will be monitored for changes in their depressive symptoms throughout the study. The goal is to determine if adding pizotifen to escitalopram can enhance treatment outcomes for patients with MDD.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed patients aged 14 to 70 years with major depressive disorder.
Not a fit: Patients with schizophrenia, bipolar disorder, or other specified medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from major depressive disorder.
How similar studies have performed: While there is existing research on escitalopram, the combination with pizotifen is less commonly studied, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rawalpindi, Punjab
- Riphah International University — Rawalpindi, Punjab, Pakistan (Recruiting)
Study contacts
- Principal investigator: Bilal Iqbal, MBBS — Riphah International University
- Study coordinator: Bilal Iqbal, MBBS
- Email: bilaliqbal8282@gmail.com
- Phone: 03038669457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.