Major Depressive Disorder
Conditions
Keywords
Pentoxifylline, Anti-inflammatory, MDD, phosphodiastrase inhibitors
Brief summary
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.
Detailed description
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.
Interventions
DRUGEscitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet
Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties
DRUGEscitalopram 20 mg tablet + Placebo
Selective serotonin reuptake inhibitor plus placebo
Sponsors
Mahmoud Samy Abdallah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Hamilton Depression rating scale score (HAM-D score) | 12 week | The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on biological markers | 12 week | Serum level of tumor necrosis factor alpha (TNF-α), Interleukin-6 (IL-6), Interleukin-10 (IL-10), brain derived neurotrophic factor (BDNF), 8-hydroxy-2'-deoxyguanosine (8-OHdG), and serotonin were measured at the baseline and after the treatment to evaluate the biological effects of the used medications. |
Outcome results
None listed