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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05030623
Other study ID # 15/2021NEUR
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2021
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Sadat City University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Antidepressant-like effects of tadalafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with tadalafil 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. Low-dose tadalafil improved both depressive symptoms in patients with erectile dysfunction.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

Drug:
Tadalafil 5Mg Tab
Tadalafil 5Mg Tab plus Fluoxetine 20 mg capsule
Placebo
Placebo Tab plus Fluoxetine 20 mg capsule

Locations

Country Name City State
Egypt Faculty of Pharmacy Shibin Al Kawm Menoufia

Sponsors (1)

Lead Sponsor Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect on Hamilton Depression rating scale score (HAM-D score) 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. 12 weeks
Secondary Effect on biological markers Serum level of tumor necrosis factor alpha (TNF-a), 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. At baseline and after 12 weeks of intervention
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