Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder

• Status: Completed
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hawler Medical University
• Treatments: Citalopram; Dexetimide; Pentoxifylline

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