Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

NCT ID: NCT06860958

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-08-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

30 patients will receive fluoxetine 20 mg/day plus placebo

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo

Comparative group

35 patients will receive fluoxetine 20 mg/day plus roflumilast

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: DRUG

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

Roflumilast

Intervention Type: 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

Interventions

Fluoxetine

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

Intervention Type: DRUG

Roflumilast

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

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta Unuversity

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mostafa M I Bahaa, PhD

Role: primary

mbahaa@horus.edu.eg

0201025538337

Other Identifiers

98421

Identifier Type: -

Identifier Source: org_study_id