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

Sponsor

Mahmoud Samy Abdallah (Other)

Overall Status

Completed

CT.gov ID

NCT03554447

Collaborator

(none)

Enrollment

Arms

44.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet Drug: Escitalopram 20 mg tablet + Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.

Actual Study Start Date :

Apr 20, 2015

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pentoxifylline group Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks	Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties
Placebo Comparator: Control group Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks	Drug: Escitalopram 20 mg tablet + Placebo Selective serotonin reuptake inhibitor plus placebo

Arm

Intervention/Treatment

Experimental: Pentoxifylline group

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

Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet

Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties

Placebo Comparator: Control group

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

Drug: Escitalopram 20 mg tablet + Placebo

Selective serotonin reuptake inhibitor plus placebo

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.