Dapagliflozin, an SGLT2 Inhibitor, From Oral Hypoglycemic Agent to Antidepressant Drug
New Trial Explores Diabetes Drug for Depression Treatment
Plain English Summary
Dapagliflozin in Depression is a Phase 2 clinical trial sponsored by Tanta University studying Depression. This trial tests if a diabetes medication called Dapagliflozin can help treat major depression. It is for adults aged 18 and older who have been diagnosed with depression for at least 2 months. Participants will receive either Dapagliflozin or Fluoxetine (a standard antidepressant) for 3 months. Standard treatments for depression include other antidepressants, therapy, and lifestyle changes. The trial aims to enroll 60 participants.
Official Summary
Major depressive disorder (MDD) is currently one of the leading causes of disability and suicidal death worldwide, and despite extensive research and massive improvements in mental health, the nature of MDD remains ambiguous. Moreover, about two-thirds of MDD patients fail to optimally respond to currently available standard therapies, and many of them suffer from treatment-resistant depression
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 or older with a diagnosis of depression for at least 2 months. Individuals must have a Hamilton Depression Rating Scale score above 18. Women of childbearing potential must have a negative pregnancy test and use effective contraception. People with bipolar disorder, personality disorders, eating disorders, substance abuse, seizure history, inflammatory disorders, or diabetes are not eligible. This trial is studying Depression, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if the depression symptoms improve significantly over 3 months, measured by a standard depression rating scale. The specific primary outcome measures are: The primary outcome measure was the 17-item HDRS. (3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses the significant unmet need for new depression treatments, as many patients do not respond well to current therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Depression, where improved treatment options are needed.
Investor Insight
This trial could signal a new therapeutic avenue for depression, potentially expanding the market for SGLT2 inhibitors beyond diabetes and heart failure. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for you, especially if current treatments haven't worked. Participation involves taking a study medication (either Dapagliflozin or Fluoxetine) for 3 months and attending regular clinic visits for assessments. You will be monitored for side effects and your depression symptoms will be tracked throughout the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 60 participants
Interventions
- DRUG: Fluoxetine — Fluoxetine is an antidepressant medication of the selective serotonin reuptake inhibitor class used for the treatment of major depressive disorder, anxiety, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and bulimia nervosa.
- DRUG: Dapagliflozin — Dapagliflozin is a medication used to treat type 2 diabetes. It is also used to treat adults with heart failure and chronic kidney disease. It reversibly inhibits sodium-glucose co-transporter 2 (SGLT-2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion.
Primary Outcomes
- The primary outcome measure was the 17-item HDRS. (3 months)
Secondary Outcomes
- Change in quality of life. (3 months)
Full Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with Hamilton rating score more than 18. Exclusion Criteria: Patients with bipolar I or bipolar II disorder, personality disorders, and eating disorders. Patients with substance dependence or abuse Patients with history of seizures or receiving electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Diabetic patients Sever kidney disorders
Trial Locations
- Mostafa Bahaa, Damietta, New Damietta, Egypt
Frequently Asked Questions
What is clinical trial NCT07239011?
NCT07239011 is a Phase 2 INTERVENTIONAL study titled "Dapagliflozin in Depression." It is currently recruiting and is sponsored by Tanta University. The trial targets enrollment of 60 participants.
What conditions does NCT07239011 study?
This trial investigates treatments for Depression. The primary condition under study is Depression.
What treatments are being tested in NCT07239011?
The interventions being studied include: Fluoxetine (DRUG), Dapagliflozin (DRUG). Fluoxetine is an antidepressant medication of the selective serotonin reuptake inhibitor class used for the treatment of major depressive disorder, anxiety, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and bulimia nervosa.
What does Phase 2 mean for NCT07239011?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07239011?
This trial is currently "Recruiting." It started on 2025-11-01. The estimated completion date is 2026-12-20.
Who is sponsoring NCT07239011?
NCT07239011 is sponsored by Tanta University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07239011?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT07239011 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07239011?
The primary outcome measures are: The primary outcome measure was the 17-item HDRS. (3 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07239011 being conducted?
This trial is being conducted at 1 site, including Damietta, New Damietta (Egypt).
Where can I find official information about NCT07239011?
The official record for NCT07239011 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07239011. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07239011 testing in simple terms?
This trial tests if a diabetes medication called Dapagliflozin can help treat major depression. It is for adults aged 18 and older who have been diagnosed with depression for at least 2 months.
Why is this trial significant?
This trial addresses the significant unmet need for new depression treatments, as many patients do not respond well to current therapies.
What are the potential risks of participating in NCT07239011?
Common side effects of Dapagliflozin can include genital yeast infections and urinary tract infections. Fluoxetine can cause side effects like nausea, insomnia, and sexual dysfunction. There is a risk of allergic reactions to the study medications. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07239011?
Ask your doctor if this trial is a good fit for you, especially if current treatments haven't worked. Participation involves taking a study medication (either Dapagliflozin or Fluoxetine) for 3 months and attending regular clinic visits for assessments. You will be monitored for side effects and your depression symptoms will be tracked throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07239011 signal from an investment perspective?
This trial could signal a new therapeutic avenue for depression, potentially expanding the market for SGLT2 inhibitors beyond diabetes and heart failure. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive either Dapagliflozin or Fluoxetine (a standard antidepressant) for 3 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Depression Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.