Using Roflumilast with Antidepressants for Major Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tanta Unuversity
  Tanta, Egypt Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brenipatide added to standard care for adults with major depressive disorder

  This study tests whether brenipatide, given alongside standard care, can help delay the return of depressive symptoms in adults with major depressive disorder.

  Recruiting at 47 sites Phase 3 Eli Lilly and Company · Birmingham, Alabama and 169 other locations · NCT07775300

• Student Precarity and Psychiatry: How Financial Struggles Relate to Depression and Loneliness

  This observational study looks at whether financial hardship and social isolation are linked to depression, suicidal thoughts, and loneliness among French university students.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, IDF · NCT07618208

• Seltorexant (JNJ-42847922) as monotherapy for adults and older adults with major depressive disorder

  This trial will test whether seltorexant works better than a placebo to reduce depressive symptoms in adults and elderly people with major depressive disorder.

  Recruiting at 53 sites Phase 3 Janssen Research & Development, LLC · Bryant, Arkansas and 52 other locations · NCT07573176

• MOCHA: Inpatient Mental Health Care for High-Risk Pregnancy

  This study tests a collaborative mental health program for pregnant or recently postpartum patients hospitalized for medical problems to see if it can be delivered feasibly and acceptably.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07540585

• Brenipatide added to standard antidepressant treatment for adults with major depression

  This trial will see if adding brenipatide to your current antidepressant treatment can delay the return of major depressive symptoms in adults with major depressive disorder.

  Recruiting at 170 sites Phase 3 Eli Lilly and Company · Moorpark, California and 179 other locations · NCT07412756

• Esketamine plus standard care for adolescents with major depressive disorder and acute suicidal thoughts or behavior

  This will test whether adding intranasal esketamine to usual care helps hospitalized adolescents with major depressive disorder and acute suicidal thoughts or behavior feel better faster than a psychoactive placebo plus usual care.

  Recruiting at 49 sites Phase 3 Janssen Research & Development, LLC · Birmingham, Alabama and 48 other locations · NCT07227454

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.