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

NCT ID: NCT05271084

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-06-08

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Citalopram + Pentoxifylline group

Citalopram (tablet): 20 mg once a day for 12 weeks + Pentoxifylline (tablet): 400 mg twice a day for 12 weeks

Group Type: EXPERIMENTAL

Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg

Intervention Type: DRUG

Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties

Control group

Citalopram (tablet): 20 mg once a day for 12 weeks + placebo (tablet) twice a day for 12 weeks

Group Type: PLACEBO_COMPARATOR

Citalopram (tablet) 20 mg + Placebo (tablet)

Intervention Type: DRUG

Selective serotonin reuptake inhibitor (SSRI) + placebo

Interventions

Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg

Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties

Intervention Type: DRUG

Citalopram (tablet) 20 mg + Placebo (tablet)

Selective serotonin reuptake inhibitor (SSRI) + placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Talar A. Merza Mohammad

Associate Professor of Department of Pharmacology and Toxicology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talar A Merzamohammad, Pharm. D

Role: PRINCIPAL_INVESTIGATOR

Hawler Medical University, College of Pharmacy, Department of Pharmacology and Toxicology

Locations

Hawler Psychiatric Hospital and Private Clinic

Erbil, , Iraq

Countries

Iraq

Other Identifiers

HMU PE-EC 16112021/382

Identifier Type: -

Identifier Source: org_study_id