NCT06860958 Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
| NCT ID | NCT06860958 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tanta University |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2025-03-01 with a primary completion date of 2027-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients
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.
Frequently Asked Questions
Who can join the NCT06860958 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06860958 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT06860958 currently recruiting?
Yes, NCT06860958 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tanta University to inquire about joining.
Where is the NCT06860958 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT06860958 clinical trial?
NCT06860958 is sponsored by Tanta University. The trial plans to enroll 60 participants.