Depression
Conditions
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.
Interventions
DRUGPizotifen
Each subject will be given 0.5mg pizotifen with 10-20mg escitalopram in patients with depressive disorder
Sponsors
Riphah International University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the severity of the depressive disorder | 4 weeks | 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). |
Countries
Pakistan
Outcome results
None listed