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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Escitalopram 20 mg tablet + Placebo; Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet

• Registration Number: NCT03554447
• Lead Sponsor: Mahmoud Samy Abdallah

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-04-20
• Primary Completion: 2017-12-01
• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-13
• Study Completion: 2018-12-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-13
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Escitalopram 20 mg tablet + Placebo	Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks
Pentoxifylline group	Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet	Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Effect on Hamilton Depression rating scale score (HAM-D score)	12 week	The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.

Secondary Outcome Measures

Name	Time	Method
Effect on biological markers	12 week	Serum level of tumor necrosis factor alpha (TNF-α), Interleukin-6 (IL-6), Interleukin-10 (IL-10), brain derived neurotrophic factor (BDNF), 8-hydroxy-2'-deoxyguanosine (8-OHdG), and serotonin were measured at the baseline and after the treatment to evaluate the biological effects of the used medications.