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Trial record 29 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

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 : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmoud Samy Abdallah, Sadat City University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet Drug: Escitalopram 20 mg tablet + Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
Actual Study Start Date : April 20, 2015
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pentoxifylline group
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
Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties

Placebo Comparator: Control group
Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks
Drug: Escitalopram 20 mg tablet + Placebo
Selective serotonin reuptake inhibitor plus placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554447


Sponsors and Collaborators
Mahmoud Samy Abdallah
Investigators
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Study Director: Sahar El-Haggar, Ph.D Faculty of Pharmacy, Tanta University
  Study Documents (Full-Text)

Documents provided by Mahmoud Samy Abdallah, Sadat City University:

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Responsible Party: Mahmoud Samy Abdallah, Principal Investigator, Sadat City University
ClinicalTrials.gov Identifier: NCT03554447     History of Changes
Other Study ID Numbers: 0074/2015
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

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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

Keywords provided by Mahmoud Samy Abdallah, Sadat City University:
Pentoxifylline
Anti-inflammatory
MDD
phosphodiastrase inhibitors

Additional relevant MeSH terms:
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Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pentoxifylline
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Phosphodiesterase Inhibitors