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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271084
• Other study ID #: HMU PE-EC 16112021/382
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 10, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: September 2022
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 8, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg
Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties
• Citalopram (tablet) 20 mg + Placebo (tablet)
Selective serotonin reuptake inhibitor (SSRI) + placebo

Locations

Country	Name	City	State
Iraq	Hawler Psychiatric Hospital and Private Clinic	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	Effect on the serum level of tumor necrosis factor-alpha (TNF-a)	Peripheral blood samples will be obtained and serum levels of TNF-a ( pg/mL) will be measured at baseline and after treatment (week 12)	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	Effect on the serum level of interleukin-1-ß (IL-1-ß)	Peripheral blood samples will be obtained and serum levels of IL-1-ß (pg/mL) will be measured at baseline and after treatment (week 12)	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks