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NCT Number: NCT07574060

Allopurinol in Depression

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Mostafa M Bahaa, PhD

SUB_INVESTIGATOR

Mostafa M I Bahaa, PhD

CONTACT

[email protected]

0201025538337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Sertraline 50 MG

Drug

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.

Allopurinol 300 MG

Drug

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

Primary outcomes

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

    Time frame: 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Allopurinol Adjuvant Therapy in Patients With Major Depressive Disorder

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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