DepressionPhase 2/3NCT07574060
Allopurinol in Depression
A Phase 2/3 study testing Sertraline 50 MG and Allopurinol 300 MG in people with Depression, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Sertraline 50 MG and Allopurinol 300 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2026to 20 May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta Unuversity
Tanta, 31527
Mostafa M I Bahaa, PhD, 0201025538337, mbahaa@horus.edu.eg
Mostafa M Bahaa, PhD
About this study
Official title: Allopurinol Adjuvant Therapy in Patients With Major Depressive Disorder
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
- Being tested
- Sertraline 50 MG, Allopurinol 300 MG
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline 50 MGDrug
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 MGDrug
Allopurinol is a potent inhibitor of the enzyme xanthine oxidase and is primarily used to treat hyperuricemia and gout
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 35 patients will receive Sertraline 50 mg/day plus a placebo. Receives: Drug: Sertraline 50 MG |
| Allopurinol group | Active comparator | 35 patients will receive 50 mg/day of sertraline plus allopurinol (300 mg/day). Receives: Drug: Sertraline 50 MG; Drug: Allopurinol 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start20 May 2026
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574060
- Sponsor's protocol ID
- 8956
- Status last verified
- Aug 2026
- First submitted
- 1 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allopurinol Adjuvant Therapy in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07574060
- Acronym / sponsor ID
- 8956
- Conditions
- Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Sertraline 50 MG35 patients will receive Sertraline 50 mg/day plus a placebo. |
| Allopurinol group | Active comparator | Drug: Sertraline 50 MG, Drug: Allopurinol 300 MG35 patients will receive 50 mg/day of sertraline plus allopurinol (300 mg/day). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sertraline 50 MGSertraline 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. | Drug | Allopurinol group, Control group |
| Allopurinol 300 MGAllopurinol is a potent inhibitor of the enzyme xanthine oxidase and is primarily used to treat hyperuricemia and gout | Drug | Allopurinol group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sertraline 50 MG and Allopurinol 300 MG in people with Depression, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 17-item Ham-D depression score. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.