Clinical trial NCT05271084: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12)
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect on the serum level of tumor necrosis factor-alpha (TNF-α)
timeFrame: 12 weeks
measure: Effect on the serum level of circulating C-reactive protein (CRP)
timeFrame: 12 weeks
measure: Effect on the serum level of interleukin 6 (IL-6)
timeFrame: 12 weeks
measure: Effect on the serum level of interleukin-1-β (IL-1-β)
timeFrame: 12 weeks
measure: Effect on the serum level of interleukin-10 (IL-10)
timeFrame: 12 weeks
measure: Effect on the serum level of brain derived neurotrophic factor (BDNF)
timeFrame: 12 weeks
measure: Effect on the serum level of serotonin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Psychiatric Hospital and Private Clinic
Study officials:
affiliation: Hawler Medical University, College of Pharmacy, Department of Pharmacology and Toxicology
name: Talar A Merzamohammad, Pharm. D
role: PRINCIPAL_INVESTIGATOR
References: