Depressive DisorderPhase 2NCT05792540
Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
A Phase 2 study testing Fluoxetine 20 mg, Dapagliflozin 10mg Tab and Atorvastatin 80mg in people with Depressive Disorder, run by Tanta University at 1 site in Egypt.
Trial summary
Major depressive disorder (MDD) is a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Fluoxetine 20 mg, Dapagliflozin 10mg Tab and Atorvastatin 80mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2023to 20 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with a Hamilton rating score of more than 18.
Who cannot join
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
- Patients with concurrent active medical conditions
- Patients with a history of seizures
Show all 11Show fewer
- Patients with a history of receiving Electroconvulsive therapy (ECT)
- Patients with inflammatory disorders
- Patients with allergies or contraindications to the used medications
- Patients with finally pregnant or lactating females
- Diabetic or hyperlipidaemic patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Menoufia University
Tanta, Shebeen El-Kom, 32511
About this study
Major depressive disorder (MDD) is a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of depression.NLRP3 inflammasome is an intracellular multiprotein complex that consists of nod-like receptor protein 3, an adaptor protein, and a procaspase-1 precursor. It is well known that a variety of danger signals, such as pathogen-associated molecular patterns and danger-associated molecular patterns can activate NLRP3 inflammasome
- Conditions
- Depressive Disorder
- Being tested
- Fluoxetine 20 mg, Dapagliflozin 10mg Tab, Atorvastatin 80mg
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine 20 mgDrug
Fluoxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive-compulsive disorder and bulimia. It works by increasing the levels of serotonin in the brain
Dapagliflozin 10mg TabDrug
Dapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor (SGLT2-I), has proven to be an effective hyperglycemic suppressor due to its role in inhibiting the reabsorption of 30-50% of the glucose filtered by the kidney, besides its role in the improvement of insulin resistance
Atorvastatin 80mgDrug
Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months Receives: Drug: Fluoxetine 20 mg |
| Dapagliflozin group | Active comparator | Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months Receives: Drug: Fluoxetine 20 mg; Drug: Dapagliflozin 10mg Tab |
| Atorvastatin group | Active comparator | Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months Receives: Drug: Fluoxetine 20 mg; Drug: Atorvastatin 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The primary endpoint is the change in Hamilton Rating Scale
- The primary endpoint is the change in Hamilton Rating Scale
Measured: 3 months
Secondary outcomes (1)
The secondary endpoint is estimated by changes in serum biomarkers.
The secondary endpoint is estimated by changes in serum biomarkers such as F) Nuclear factor erythroid 2-related factor 2
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start6 Jun 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792540
- Sponsor's protocol ID
- 4/2023
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aldossary KM, Ali LS, Abdallah MS, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El Sabaa RM, Elmorsi YM, Kamel MM, Negm WA, Elberri AI, Hamouda AO, AlRasheed HA, Salahuddin MM, Yasser M, Hamouda MA. Effect of a high dose atorvastatin as added-on therapy on symptoms and serum AMPK/NLRP3 inflammasome and IL-6/STAT3 axes in patients with major depressive disorder: randomized controlled clinical study. Front Pharmacol. 2024 May 24;15:1381523. doi: 10.3389/fphar.2024.1381523. eCollection 2024.
PubMed 38855751
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
- ClinicalTrials.gov ID
- NCT05792540
- Acronym / sponsor ID
- 4/2023
- Conditions
- Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 31 Mar 2023 (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 a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of depression.NLRP3 inflammasome is an intracellular multiprotein complex that consists of nod-like receptor protein 3, an adaptor protein, and a procaspase-1 precursor. It is well known that a variety of danger signals, such as pathogen-associated molecular patterns and danger-associated molecular patterns can activate NLRP3 inflammasome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Fluoxetine 20 mgControl group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months |
| Dapagliflozin group | Active comparator | Drug: Fluoxetine 20 mg, Drug: Dapagliflozin 10mg TabPatients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months |
| Atorvastatin group | Active comparator | Drug: Fluoxetine 20 mg, Drug: Atorvastatin 80mgPatients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with a Hamilton rating score of more than 18.
Key exclusion criteria (11 listed)
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
- Patients with concurrent active medical conditions
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 |
|---|---|---|
| Fluoxetine 20 mgFluoxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive-compulsive disorder and bulimia. It works by increasing the levels of serotonin in the brain | Drug | Atorvastatin group, Control Group, Dapagliflozin group |
| Dapagliflozin 10mg TabDapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor (SGLT2-I), has proven to be an effective hyperglycemic suppressor due to its role in inhibiting the reabsorption of 30-50% of the glucose filtered by the kidney, besides its role in the improvement of insulin resistance | Drug | Dapagliflozin group |
| Atorvastatin 80mgAtorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia | Drug | Atorvastatin group |
Primary outcome
• The primary endpoint is the change in Hamilton Rating Scale
Time frame: 3 months
• The primary endpoint is the change in Hamilton Rating Scale
1 secondary outcome
The secondary endpoint is estimated by changes in serum biomarkers.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 38855751Aldossary KM, Ali LS, Abdallah MS, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El Sabaa RM, Elmorsi YM, Kamel MM, Negm WA, Elberri AI, Hamouda AO, AlRasheed HA, Salahuddin MM, Yasser M, Hamouda MA. Effect of a high dose atorvastatin as added-on therapy on symptoms and serum AMPK/NLRP3 inflammasome and IL-6/STAT3 axes in patients with major depressive disorder: randomized controlled clinical study. Front Pharmacol. 2024 May 24;15:1381523. doi: 10.3389/fphar.2024.1381523. eCollection 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine 20 mg, Dapagliflozin 10mg Tab and Atorvastatin 80mg in people with Depressive Disorder, 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 11 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: finished, as of the sponsor's last update on 30 Oct 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The primary endpoint is the change in Hamilton Rating Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792540, which also lists 1 linked publication.
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 30 Oct 2026.