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

Hawler Medical University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Major Depressive Disorder

Treatments

Drug: Citalopram (tablet) 20 mg + Placebo (tablet)

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05271084

HMU PE-EC 16112021/382

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No 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