Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

NCT06860958 | Recruiting Phase 3

• 1 other identifier: 98421
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• The principal measure of the outcome will be the 17-item Ham-D

  2\. Patients will be assessed by a psychiatrist at baseline, 4, and 8 weeks after starting the medication. The principal measure of the outcome will be the 17-item Ham-D.

  2 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

30 patients will receive fluoxetine 20 mg/day plus placebo

Drug: Fluoxetine; Drug: Placebo

Comparative group

ACTIVE COMPARATOR

35 patients will receive fluoxetine 20 mg/day plus roflumilast

Drug: Fluoxetine; Drug: Roflumilast

Interventions

Fluoxetine DRUG

Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs)

Comparative group; Control group

Roflumilast DRUG

Roflumilast is the first drug targeting PDE4 that was marketed for treatment of chronic obstructive pulmonary disease (COPD) with relatively weak potency inducing nausea and vomiting

Comparative group

Placebo DRUG

Placebo

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Pregnant women or women not using medically accepted means of birth control are excluded.
• 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.
• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fluoxetine; Roflumilast

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

EG (1)