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Completed

NCT Number: NCT05271084

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hawler Psychiatric Hospital and Private Clinic

Erbil, 44001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg

Drug

Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties

Citalopram (tablet) 20 mg + Placebo (tablet)

Drug

Selective serotonin reuptake inhibitor (SSRI) + placebo

Primary outcomes

  1. Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12)

    Time frame: 12 weeks

    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 outcomes

  1. Effect on the serum level of tumor necrosis factor-alpha (TNF-α)

    Time frame: 12 weeks

    Peripheral blood samples will be obtained and serum levels of TNF-α ( pg/mL) will be measured at baseline and after treatment (week 12)

  2. Effect on the serum level of circulating C-reactive protein (CRP)

    Time frame: 12 weeks

    Peripheral blood samples will be obtained and serum levels of CRP (mg/dL) will be measured at baseline and after treatment (week 12)

  3. Effect on the serum level of interleukin 6 (IL-6)

    Time frame: 12 weeks

    Peripheral blood samples will be obtained and serum levels of IL-6 (pg/mL) will be measured at baseline and after treatment (week 12)

  4. Effect on the serum level of interleukin-1-β (IL-1-β)

    Time frame: 12 weeks

    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)

  5. Effect on the serum level of interleukin-10 (IL-10)

    Time frame: 12 weeks

    Peripheral blood samples will be obtained and serum levels of IL-10 (pg/mL) will be measured at baseline and after treatment (week 12)

  6. Effect on the serum level of brain derived neurotrophic factor (BDNF)

    Time frame: 12 weeks

    Peripheral blood samples will be obtained and serum levels of BDNF (ng/mL) will be measured at baseline and after treatment (week 12)

  7. Effect on the serum level of serotonin

    Time frame: 12 weeks

    Peripheral blood samples will be obtained and serum levels of serotonin (ng/mL) will be measured at baseline and after treatment (week 12)

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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