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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554447
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Samy Abdallah, Sadat City University

Tracking Information
First Submitted Date  ICMJE May 31, 2018
First Posted Date  ICMJE June 13, 2018
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE April 20, 2015
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Effect on Hamilton Depression rating scale score (HAM-D score) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
The principal measure of the outcome was the 17-items HAM-D. 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Effect on biological markers [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
Serum level of TNF-α, IL-6, IL-10, BDNF, 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
Official Title  ICMJE Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet
    Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties
  • Drug: Escitalopram 20 mg tablet + Placebo
    Selective serotonin reuptake inhibitor plus placebo
Study Arms  ICMJE
  • Experimental: Pentoxifylline group
    Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks
    Intervention: Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet
  • Placebo Comparator: Control group
    Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks
    Intervention: Drug: Escitalopram 20 mg tablet + Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2018)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03554447
Other Study ID Numbers  ICMJE 0074/2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mahmoud Samy Abdallah, Sadat City University
Study Sponsor  ICMJE Mahmoud Samy Abdallah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sahar El-Haggar, Ph.D Faculty of Pharmacy, Tanta University
PRS Account Sadat City University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP