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

NCT05271084 | Completed Phase 1 DMC

• 1 other identifier: HMU PE-EC 16112021/382
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (7)

• Effect on the serum level of tumor necrosis factor-alpha (TNF-α)

  12 weeks

• Effect on the serum level of circulating C-reactive protein (CRP)

  12 weeks

• Effect on the serum level of interleukin 6 (IL-6)

  12 weeks

• Effect on the serum level of interleukin-1-β (IL-1-β)

  12 weeks

• Effect on the serum level of interleukin-10 (IL-10)

  12 weeks

Study Arms (2)

Citalopram + Pentoxifylline group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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)

Interventions

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

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

Citalopram + Pentoxifylline group

Citalopram (tablet) 20 mg + Placebo (tablet) DRUG

Selective serotonin reuptake inhibitor (SSRI) + placebo

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Psychiatric Hospital and Private Clinic

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Citalopram; Tablets; Pentoxifylline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Theobromine; Xanthines; Purinones; Purines

Study Officials

• Talar A Merzamohammad, Pharm. D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Department of Pharmacology and Toxicology

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 8, 2022
• Study Start: November 10, 2021
• Primary Completion: February 25, 2022
• Study Completion: June 8, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)