Using Roflumilast with Antidepressants for Major Depression

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

This study is testing if adding Roflumilast to the antidepressant Fluoxetine can help people with major depression who aren't getting better with their current treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Locations: 1 site (Tanta)
• Trial ID: NCT06860958 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Roflumilast as an additional treatment for patients with Major Depressive Disorder (MDD) who are already receiving antidepressants. The study aims to determine if combining Roflumilast with Fluoxetine can enhance therapeutic outcomes for patients who do not respond adequately to standard antidepressant therapy. Participants will be assessed based on their depression severity using the Hamilton Depression Rating Scale (Ham-D). The trial will involve a comparison between the combination treatment and a placebo.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with a Ham-D score of at least 18 indicating significant depressive symptoms.

Not a fit: Patients with bipolar disorder, severe suicidal ideation, or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with Major Depressive Disorder who do not respond to existing antidepressants.

How similar studies have performed: While the combination of medications for MDD is a common approach, the specific use of Roflumilast in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Patients with age greater than 18 years old.
2. Patients with Ham-D score at least 18 with item 1 depressed mood scored 2 or greater are eligible.

Exclusion Criteria:

1. Patients with bipolar I or bipolar II disorder; eating disorders, personality disorders, and mental retardation, current diagnosis anxiety disorders (except for specific phobia), mental disorder due to general medical condition; met criteria for substance dependence or abuse in the previous three months; have a concurrent medical illness or history of seizures that would contraindicate use of the study medication and are receiving Electroconvulsive therapy (ECT).
2. Pregnant women or women not using medically accepted means of birth control are excluded.
3. Persons who score greater than 2 on the suicide item of the Ham-D, or who are judged to have significant suicidal ideation or potential in the view of an investigator, are excluded.
4. Patients who are required to be free of all psychotropic except for escitalopram and anti-inflammatory medications for at least four weeks before study entry.

Where this trial is running

Tanta

• Tanta Unuversity — Tanta, Egypt (Recruiting)

Conditions Depressive Disorder, Major