Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Last updated: March 16, 2025
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

3

Condition

Depression

Treatment

Placebo

Roflumilast

Fluoxetine

Clinical Study ID

NCT06860958
98421
  • Ages 18-65
  • All Genders

Study 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

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 greaterare eligible.

Exclusion

Exclusion Criteria:

  1. Patients with bipolar I or bipolar II disorder; eating disorders, personalitydisorders, and mental retardation, current diagnosis anxiety disorders (except forspecific phobia), mental disorder due to general medical condition; met criteria forsubstance dependence or abuse in the previous three months; have a concurrentmedical illness or history of seizures that would contraindicate use of the studymedication and are receiving Electroconvulsive therapy (ECT).

  2. Pregnant women or women not using medically accepted means of birth control areexcluded.

  3. Persons who score greater than 2 on the suicide item of the Ham-D, or who are judgedto 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 andanti-inflammatory medications for at least four weeks before study entry.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
August 20, 2026

Connect with a study center

  • Tanta Unuversity

    Tanta, 31527
    Egypt

    Active - Recruiting

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