Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder

Mahmoud Samy Abdallah

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet; Drug: Escitalopram 20 mg tablet + Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03554447

0074/2015

Details and patient eligibility

About

This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.

Full description

In this study, the investigators evaluated the potential antidepressant effect of PTX in adult patients with MDD. the investigators hypothesized that MDD patients taking add-on PTX would present greater amelioration of their depressive symptoms than patients taking add-on placebo. Furthermore, the investigators assessed the relationship between HAM-D score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of MDD.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
• Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion criteria

• Patients with bipolar I or bipolar II disorder
• Patients with personality disorders
• Patients with eating disorders
• Patients with substance dependence or abuse
• Patients with concurrent active medical condition
• Patients with history of seizures
• Patients with history of receiving Electroconvulsive therapy (ECT)
• Patients with inflammatory disorders
• Patients with allergy or contraindications to the used medications
• Patients with finally pregnant or lactating females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Pentoxifylline group

Experimental group

Description:

Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks

Treatment:

Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet

Control group

Placebo Comparator group

Description:

Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks

Treatment:

Drug: Escitalopram 20 mg tablet + Placebo