Back to resultsRole of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet
Escitalopram 20 mg tablet + Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Pentoxifylline, Anti-inflammatory, MDD, phosphodiastrase inhibitors
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pentoxifylline group
Control group
Arm Description
Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks
Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Effect on biological markers
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03554447
Brief Title
Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
Official Title
Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2015 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud Samy Abdallah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Pentoxifylline, Anti-inflammatory, MDD, phosphodiastrase inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pentoxifylline group
Arm Type
Experimental
Arm Description
Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet
Intervention Description
Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties
Intervention Type
Drug
Intervention Name(s)
Escitalopram 20 mg tablet + Placebo
Intervention Description
Selective serotonin reuptake inhibitor plus placebo
Primary Outcome Measure Information:
Title
Effect on Hamilton Depression rating scale score (HAM-D score)
Description
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.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Effect on biological markers
Description
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.
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar El-Haggar, Ph.D
Organizational Affiliation
Faculty of Pharmacy, Tanta University
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://www.karger.com/Article/Abstract/492619
Description
The Phosphodiesterase Inhibitor Pentoxifylline as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Learn more about this trial
Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
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