Allopurinol in Depression

NCT07574060 | Not Yet Recruiting Phase 2

• 1 other identifier: 8956
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Outcome Measures

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).

  8 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Drug: Sertraline 50 MG

Allopurinol group

ACTIVE COMPARATOR

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

Drug: Sertraline 50 MG; Drug: Allopurinol 300 MG

Interventions

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 group; Control group

Allopurinol 300 MG DRUG

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

Allopurinol group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

Location

MeSH Terms

Conditions

Depression

Interventions

Sertraline; Allopurinol

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

EG (1)