Major Depressive Disorder
Conditions
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.
Interventions
DRUGCitalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg
Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties
DRUGCitalopram (tablet) 20 mg + Placebo (tablet)
Selective serotonin reuptake inhibitor (SSRI) + placebo
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12) | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect on the serum level of tumor necrosis factor-alpha (TNF-α) | 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) |
| Effect on the serum level of circulating C-reactive protein (CRP) | 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) |
| Effect on the serum level of interleukin-1-β (IL-1-β) | 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) |
| Effect on the serum level of interleukin 6 (IL-6) | 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) |
| Effect on the serum level of brain derived neurotrophic factor (BDNF) | 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) |
| Effect on the serum level of serotonin | 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) |
| Effect on the serum level of interleukin-10 (IL-10) | 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) |
Countries
Iraq
Outcome results
None listed