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

NCT03554447 | Completed DMC

• 1 other identifier: 0074/2015
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Keywords

Pentoxifylline; Anti-inflammatory; MDD; phosphodiastrase inhibitors

Outcome Measures

Primary Outcomes (1)

• Effect on Hamilton Depression rating scale score (HAM-D score)

  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.

  12 week

Secondary Outcomes (1)

• Effect on biological markers

  12 week

Study Arms (2)

Pentoxifylline group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Drug: Escitalopram 20 mg tablet + Placebo

Interventions

Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet DRUG

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

Pentoxifylline group

Escitalopram 20 mg tablet + Placebo DRUG

Selective serotonin reuptake inhibitor plus placebo

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahmoud Samy Abdallah: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram; Tablets; Pentoxifylline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Theobromine; Xanthines; Purinones; Purines

Study Officials

• Sahar El-Haggar, Ph.D

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 13, 2018
• Study Start: April 20, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06