A Phase 1/2 interventional study of Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg and Citalopram (tablet) 20 mg + Placebo (tablet) in Major Depressive Disorder, sponsored by Hawler Medical University. Completed at 1 site in Iraq. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Hawler Medical University · Phase 1/2, Interventional, and Treatment
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.
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.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Hawler Medical University is the lead sponsor of 59 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Citalopram (tablet): 20 mg once a day for 12 weeks + Pentoxifylline (tablet): 400 mg twice a day for 12 weeks
Drug: Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg
Citalopram (tablet): 20 mg once a day for 12 weeks + placebo (tablet) twice a day for 12 weeks
Drug: Citalopram (tablet) 20 mg + Placebo (tablet)
Drug page: Citalopram
Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties
Selective serotonin reuptake inhibitor (SSRI) + placebo
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).
Time frame: 12 weeks
Effect on the serum level of tumor necrosis factor-alpha (TNF-α)
Peripheral blood samples will be obtained and serum levels of TNF-α ( pg/mL) will be measured at baseline and after treatment (week 12)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
Effect on the serum level of interleukin-1-β (IL-1-β)
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Citalopram
Hawler Medical University