Depression
Conditions
Brief summary
Major depressive disorder (MDD) is currently one of the leading causes of disability and suicidal death worldwide, and despite extensive research and massive improvements in mental health, the nature of MDD remains ambiguous. Moreover, about two-thirds of MDD patients fail to optimally respond to currently available standard therapies, and many of them suffer from treatment-resistant depression
Interventions
DRUGFluoxetine
Fluoxetine is an antidepressant medication of the selective serotonin reuptake inhibitor class used for the treatment of major depressive disorder, anxiety, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and bulimia nervosa.
DRUGDapagliflozin
Dapagliflozin is a medication used to treat type 2 diabetes. It is also used to treat adults with heart failure and chronic kidney disease. It reversibly inhibits sodium-glucose co-transporter 2 (SGLT-2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with Hamilton rating score more than 18.
Exclusion criteria
Patients with bipolar I or bipolar II disorder, personality disorders, and eating disorders. Patients with substance dependence or abuse Patients with history of seizures or receiving electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Diabetic patients Sever kidney disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure was the 17-item HDRS. | 3 months | All patients will be assessed via Hamilton Depression Rating Scale (HDRS). A HDRS score of ≤ 7 indicates remission or partial remission \[HDRS\<17 and\>7\]. Response was defined as ≥ 50% drop in the HDRS score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life. | 3 months | Change in quality of life will be assessed through Short Form-36 Health Survey. One of the most commonly used quality of life tools. It consists of 36 items, and 8 domains |
Countries
Egypt
Outcome results
None listed