Major Depressive Disorder
Conditions
Brief summary
Antidepressant-like effects of sildenafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with sildenafil was shown to be PKG-dependent and lead to increased expression of cGMP, pCREB, BDNF and VGF in the hippocampus and prefrontal cortex (PFC), brain areas relevant to mood disorders pathophysiology. Sildenafil produces antidepressant-like effects by inhibiting oxidative stress in the hippocampus and by decreasing the levels of IL-1β in the hippocampus and striatum.
Interventions
DRUGSildenafil Citrate
Esitalopram 20 mg tablet plus Sildenafil Citrate 50 mg tablet once daily
DRUGPlacebo oral tablet
Esitalopram 20 mg tablet plus placebo tablet once daily
Sponsors
Sadat City 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
* Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960). * Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.
Exclusion criteria
* Patients with bipolar I or bipolar II disorder * Patients with personality disorders * Patients with eating disorders * Patients with substance dependence or abuse * Patients with concurrent active medical condition * Patients with history of seizures * Patients with history of receiving Electroconvulsive therapy (ECT) * Patients with inflammatory disorders * Patients with allergy or contraindications to the used medications * Patients with finally pregnant or lactating females * Cardiovascular disorders * Severe renal impairment: creatinine clearance of ≤ 25 ml/min * Moderate or severe hepatic impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Hamilton Depression rating scale score (HAM-D score) | 12 week | The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on biological markers | 12 week | Serum level of tumor necrosis factor alpha (TNF-α), Interleukin-6 (IL-6), and brain derived neurotrophic factor (BDNF) were measured at the baseline and after the treatment to evaluate the biological effects of the used medications. |
Countries
Egypt
Outcome results
None listed