The Phosphodiesterase Inhibitor Tadalafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Last updated: July 9, 2025
Sponsor: Sadat City University
Overall Status: Trial Not Available

Phase

1/2

Condition

Affective Disorders

Depression (Major/severe)

Depression

Treatment

Placebo

Tadalafil 5Mg Tab

Clinical Study ID

NCT05030623
15/2021NEUR
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
August 01, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Faculty of Pharmacy

    Shibīn Al Kawm, Menoufia 13829
    Egypt

    Site Not Available

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