Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
Lead SponsorSadat City University
StatusCompleted No Results Posted
Indication/ConditionMajor Depressive Disorder
Intervention/TreatmentEscitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet [escitalopram (32278), pentoxifylline (77558)] Escitalopram 20 mg tablet + Placebo
This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.
In this study, the investigators evaluated the potential antidepressant effect of PTX in adult patients with MDD. the investigators hypothesized that MDD patients taking add-on PTX would present greater amelioration of their depressive symptoms than patients taking add-on placebo. Furthermore, the investigators assessed the relationship between HAM-D score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of MDD.
Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties
Selective serotonin reuptake inhibitor plus placebo
Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks
Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks
Inclusion Criteria: Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960). Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study. Exclusion Criteria: Patients with bipolar I or bipolar II disorder Patients with personality disorders Patients with eating disorders Patients with substance dependence or abuse Patients with concurrent active medical condition Patients with history of seizures Patients with history of receiving Electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females