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Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg
Citalopram (tablet) 20 mg + Placebo (tablet)
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide written, voluntary informed consent prior to study enrollment.
  • Male or female between the ages of 21 to 65.
  • Patient must be diagnosed with a moderate to a severe depressive episode, as determined by the MADRS score >21.
  • Prior to taking part in the trial, all patients were requested to abstain from all psychotropic and anti-inflammatory medications for at least four weeks.

Exclusion Criteria:

  • Current psychotic symptoms or perceptual problems of any kind, at the discretion of the investigator
  • The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy
  • The presence of cardiovascular diseases, including high blood pressure, a recent myocardial infarction, cardiac arrhythmia, coronary artery disease, or a coagulation disorder
  • Renal impairment, defined as creatinine clearance less than 80ml/min
  • Patients who have previously received electroconvulsive therapy (ECT)
  • Patients who have inflammatory disorders
  • Patients with a concurrent active medical condition
  • Patients with a history of seizures
  • Patients who are pregnant or nursing females.
  • Patients with bipolar I or bipolar II disorder
  • Patients with personality disorders
  • Patients with eating disorders
  • Patients with substance dependence or abuse

Sites / Locations

  • Hawler Psychiatric Hospital and Private Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Citalopram + Pentoxifylline group

Control group

Arm Description

Citalopram (tablet): 20 mg once a day for 12 weeks + Pentoxifylline (tablet): 400 mg twice a day for 12 weeks

Citalopram (tablet): 20 mg once a day for 12 weeks + placebo (tablet) twice a day for 12 weeks

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12)
The HDRS is a 17-item scale that asks participants to rate the severity of their depression symptoms. Scoring is based on the 17-item scale. The total score ranges from 0 to 52, with higher numbers demonstrating more severe symptoms. Normal scores range from 0 to 7, mild depression ranges from 8 to 16, moderate depression ranges from 17 to 23, and scores of 24 and greater indicate severe depression. Remission is defined as HDRS total score ≤ 7 (primary outcome).

Secondary Outcome Measures

Effect on the serum level of tumor necrosis factor-alpha (TNF-α)
Peripheral blood samples will be obtained and serum levels of TNF-α ( pg/mL) will be measured at baseline and after treatment (week 12)
Effect on the serum level of circulating C-reactive protein (CRP)
Peripheral blood samples will be obtained and serum levels of CRP (mg/dL) will be measured at baseline and after treatment (week 12)
Effect on the serum level of interleukin 6 (IL-6)
Peripheral blood samples will be obtained and serum levels of IL-6 (pg/mL) will be measured at baseline and after treatment (week 12)
Effect on the serum level of interleukin-1-β (IL-1-β)
Peripheral blood samples will be obtained and serum levels of IL-1-β (pg/mL) will be measured at baseline and after treatment (week 12)
Effect on the serum level of interleukin-10 (IL-10)
Peripheral blood samples will be obtained and serum levels of IL-10 (pg/mL) will be measured at baseline and after treatment (week 12)
Effect on the serum level of brain derived neurotrophic factor (BDNF)
Peripheral blood samples will be obtained and serum levels of BDNF (ng/mL) will be measured at baseline and after treatment (week 12)
Effect on the serum level of serotonin
Peripheral blood samples will be obtained and serum levels of serotonin (ng/mL) will be measured at baseline and after treatment (week 12)

Full Information

First Posted
February 23, 2022
Last Updated
September 5, 2022
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05271084
Brief Title
Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder
Official Title
Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
June 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to test if combining the antidepressant Citalopram with Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties, enhanced antidepressant efficacy in adult patients with major depressive disorder (MDD) when compared to Citalopram alone.
Detailed Description
According to mounting evidence, inflammation and phosphodiesterase (PDE) pathways may play a role in the pathogenesis of psychiatric diseases such as MDD. PTX is a phosphodiesterase inhibitor and has anti-inflammatory and antioxidant effects. Therefore, it has been hypothesized that MDD patients taking combined administration of the Citalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), and PTX would show a higher improvement in depression symptoms. The relationship between the Hamilton Depression Rating Scale-17 items (Ham-D-17) score and various biological markers and their potential role in the therapeutic outcome of MDD will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citalopram + Pentoxifylline group
Arm Type
Experimental
Arm Description
Citalopram (tablet): 20 mg once a day for 12 weeks + Pentoxifylline (tablet): 400 mg twice a day for 12 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Citalopram (tablet): 20 mg once a day for 12 weeks + placebo (tablet) twice a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg
Intervention Description
Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties
Intervention Type
Drug
Intervention Name(s)
Citalopram (tablet) 20 mg + Placebo (tablet)
Intervention Description
Selective serotonin reuptake inhibitor (SSRI) + placebo
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12)
Description
The HDRS is a 17-item scale that asks participants to rate the severity of their depression symptoms. Scoring is based on the 17-item scale. The total score ranges from 0 to 52, with higher numbers demonstrating more severe symptoms. Normal scores range from 0 to 7, mild depression ranges from 8 to 16, moderate depression ranges from 17 to 23, and scores of 24 and greater indicate severe depression. Remission is defined as HDRS total score ≤ 7 (primary outcome).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect on the serum level of tumor necrosis factor-alpha (TNF-α)
Description
Peripheral blood samples will be obtained and serum levels of TNF-α ( pg/mL) will be measured at baseline and after treatment (week 12)
Time Frame
12 weeks
Title
Effect on the serum level of circulating C-reactive protein (CRP)
Description
Peripheral blood samples will be obtained and serum levels of CRP (mg/dL) will be measured at baseline and after treatment (week 12)
Time Frame
12 weeks
Title
Effect on the serum level of interleukin 6 (IL-6)
Description
Peripheral blood samples will be obtained and serum levels of IL-6 (pg/mL) will be measured at baseline and after treatment (week 12)
Time Frame
12 weeks
Title
Effect on the serum level of interleukin-1-β (IL-1-β)
Description
Peripheral blood samples will be obtained and serum levels of IL-1-β (pg/mL) will be measured at baseline and after treatment (week 12)
Time Frame
12 weeks
Title
Effect on the serum level of interleukin-10 (IL-10)
Description
Peripheral blood samples will be obtained and serum levels of IL-10 (pg/mL) will be measured at baseline and after treatment (week 12)
Time Frame
12 weeks
Title
Effect on the serum level of brain derived neurotrophic factor (BDNF)
Description
Peripheral blood samples will be obtained and serum levels of BDNF (ng/mL) will be measured at baseline and after treatment (week 12)
Time Frame
12 weeks
Title
Effect on the serum level of serotonin
Description
Peripheral blood samples will be obtained and serum levels of serotonin (ng/mL) will be measured at baseline and after treatment (week 12)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide written, voluntary informed consent prior to study enrollment. Male or female between the ages of 21 to 65. Patient must be diagnosed with a moderate to a severe depressive episode, as determined by the MADRS score >21. Prior to taking part in the trial, all patients were requested to abstain from all psychotropic and anti-inflammatory medications for at least four weeks. Exclusion Criteria: Current psychotic symptoms or perceptual problems of any kind, at the discretion of the investigator The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy The presence of cardiovascular diseases, including high blood pressure, a recent myocardial infarction, cardiac arrhythmia, coronary artery disease, or a coagulation disorder Renal impairment, defined as creatinine clearance less than 80ml/min Patients who have previously received electroconvulsive therapy (ECT) Patients who have inflammatory disorders Patients with a concurrent active medical condition Patients with a history of seizures Patients who are pregnant or nursing females. Patients with bipolar I or bipolar II disorder Patients with personality disorders Patients with eating disorders Patients with substance dependence or abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talar A Merzamohammad, Pharm. D
Organizational Affiliation
Hawler Medical University, College of Pharmacy, Department of Pharmacology and Toxicology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawler Psychiatric Hospital and Private Clinic
City
Erbil
ZIP/Postal Code
44001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder

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