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

Last updated: November 20, 2023
Sponsor: Sadat City University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Affective Disorders

Depression (Adult And Geriatric)

Depression (Major/severe)

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) (AmericanPsychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and atotal 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greaterwere eligible (Hamilton, 1960). Patients were requested to be free of all the psychotropic and anti-inflammatorymedications 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 Patientswith eating disorders Patients with substance dependence or abuse Patients with concurrentactive medical condition Patients with history of seizures Patients with history ofreceiving Electroconvulsive therapy (ECT) Patients with inflammatory disorders Patientswith allergy or contraindications to the used medications Patients with finally pregnant orlactating females Cardiovascular disorders Severe renal impairment: creatinine clearance of ≤ 25 ml/min Moderate or severe hepatic impairment

Study Design

Total Participants: 100
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

    Active - Recruiting

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