Using Roflumilast to enhance antidepressant effects in patients with major depressive disorder
The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients. Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
This study is testing if adding Roflumilast to standard antidepressants can help adults with major depressive disorder feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sadat City University Academic / other |
| Locations | 1 site (Shibeen Elkom, Menoufia) |
| Trial ID | NCT04751071 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Roflumilast, a phosphodiesterase-4 inhibitor, as an adjunct treatment for adults diagnosed with major depressive disorder (MDD). The research aims to determine if Roflumilast can enhance the effects of standard antidepressants by preventing the breakdown of cyclic AMP, which plays a crucial role in neurotransmitter release and neuroprotection. Participants will be assessed using the Hamilton Depression Rating Scale (HAM-D) to measure changes in depressive symptoms and the relationship between these symptoms and brain-derived neurotrophic factor (BDNF). The study will involve a comparison between Roflumilast and a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are adult outpatients diagnosed with major depressive disorder who have a HAM-D score of at least 20.
Not a fit: Patients with bipolar disorder, personality disorders, or those with substance dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new adjunctive option for patients with major depressive disorder, potentially improving their overall treatment outcomes.
How similar studies have performed: While PDE4 inhibitors have shown promise in pre-clinical studies, this specific approach with Roflumilast in MDD is novel and has not been extensively tested in prior 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 20 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960). 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
Shibeen Elkom, Menoufia
- Faculty of Pharmacy — Shibeen Elkom, 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.