Using tadalafil to enhance antidepressant effects in patients with major depression
The Phosphodiesterase Inhibitor Tadalafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients: Randomized, Double-Blind, Placebo-Controlled Trial
This study is testing if adding tadalafil, a medication usually for erectile dysfunction, can help improve mood in adults with major depression.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Sadat City University Academic / other |
| Locations | 1 site (Shibīn Al Kawm, Menoufia) |
| Trial ID | NCT05030623 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of tadalafil, a phosphodiesterase inhibitor, as an adjunct treatment for patients diagnosed with Major Depressive Disorder (MDD). The study aims to explore tadalafil's potential antidepressant-like effects by modulating neuroplasticity-related pathways in the brain, particularly in areas associated with mood regulation. Participants will receive either tadalafil or a placebo while being monitored for changes in depressive symptoms. The trial includes adult outpatients who meet specific diagnostic criteria and have been off psychotropic medications for a designated period.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Major Depressive Disorder who are not currently on psychotropic medications.
Not a fit: Patients with bipolar disorder, personality disorders, or those with a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel adjunctive option for patients with major depression, potentially improving their overall treatment outcomes.
How similar studies have performed: While the use of tadalafil for erectile dysfunction has shown benefits, its application as an adjunct treatment for depression is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shibīn Al Kawm, Menoufia
- Faculty of Pharmacy — Shibīn Al Kawm, Menoufia, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.