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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-20

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pentoxifylline group

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

Group Type EXPERIMENTAL

Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Escitalopram 20 mg tablet + Placebo

Intervention Type DRUG

Selective serotonin reuptake inhibitor plus placebo

Interventions

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Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet

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

Intervention Type DRUG

Escitalopram 20 mg tablet + Placebo

Selective serotonin reuptake inhibitor plus placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No