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RecruitingNCT07574060Updated Aug 18, 2026

Allopurinol in Depression

A Phase 2/3 interventional study of Sertraline 50 MG and Allopurinol 300 MG in Depression, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Tanta University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients.

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Conditions studied

  • Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 70 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients aged greater than 18 years old. Patients with a HAM-D score of at least 10 with item 1, depressed mood, scoring 2 or greater, are eligible.

Exclusion criteria

Exclusion Criteria:

Patients with bipolar I or bipolar II disorder Patients with eating disorders Pregnant women or women not using medically accepted means of birth control Cardiovascular disorders Severe renal impairment

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Control group

    35 patients will receive Sertraline 50 mg/day plus a placebo.

    Drug: Sertraline 50 MG

  • Active comparator
    Allopurinol group

    35 patients will receive 50 mg/day of sertraline plus allopurinol (300 mg/day).

    Drug: Sertraline 50 MG · Drug: Allopurinol 300 MG

Interventions

  • DrugSertraline 50 MG

    Sertraline is an antidepressant medication of the selective serotonin reuptake inhibitor class used to treat major depressive disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder.

  • DrugAllopurinol 300 MG

    Allopurinol is a potent inhibitor of the enzyme xanthine oxidase and is primarily used to treat hyperuricemia and gout

06

What researchers measure

Primary outcomes

  1. Change in the 17-item Ham-D depression score.

    Ham-D depression is a widely used clinician-administered instrument designed to assess the severity of depressive symptoms over the preceding week. It consists of 17 items. Higher scores indicate greater severity of depression, with commonly accepted cutoffs being 0-7 (normal), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (severe depression), and 23 or above (very severe depression).

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Tanta Unuversity
    Tanta, 31527, Egypt
    • Mostafa M I Bahaa, PhD · Contact · mbahaa@horus.edu.eg · 0201025538337
    • Mostafa M Bahaa, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07574060
Lead sponsor
Tanta University
Responsible party
Mostafa Bahaa (Lecturer, Tanta University) — Principal investigator
First posted
May 7, 2026
Start date
May 20, 2026
Primary completion
May 20, 2027 (estimated)
Completion
May 20, 2027 (estimated)
Last update
Aug 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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