Trial | NCT03554447  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
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 Started
Apr 20
2015
Primary Completion
Dec 01
2017
Study Completion
Dec 31
2018
Last Update
Jun 16
2020

Drug Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet [escitalopram (lexapro), pentoxifylline (trental)]

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

Drug Escitalopram 20 mg tablet + Placebo

Selective serotonin reuptake inhibitor plus placebo

Pentoxifylline group Experimental

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

Control group Placebo Comparator

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

Criteria 

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
No Results Posted