Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder: A Randomized Controlled Trial

New Depression Treatment Trial Compares Dextromethorphan-Bupropion to SSRIs

NCT: NCT06957223 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: Asad Ullah Jan · Started: 2025-05-06 · Est. Completion: 2025-12-31

Plain English Summary

Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder is a Not Applicable clinical trial sponsored by Asad Ullah Jan studying Major Depressive Disorder (MDD). This trial tests if a new combination drug (dextromethorphan-bupropion) works better than common antidepressants (SSRIs) for major depression. It's for adults diagnosed with moderate to severe major depressive disorder. Participants will take either the new drug or an SSRI for 6 weeks and have their depression symptoms assessed. Standard treatment for major depression includes SSRIs, SNRIs, and psychotherapy. The trial aims to enroll 80 participants.

Official Summary

The study aims to compare the antidepressant effects of a dextromethorphan-bupropion combination versus standard SSRI therapy in adult patients with major depressive disorder. Participants will be randomized into two groups: one receiving dextromethorphan-bupropion and the other receiving an SSRI (e.g., sertraline or escitalopram). Treatment will last for 6 weeks, with assessments at baseline and study completion. The primary outcome will be the remission rate measured by a validated depression rating scale. Secondary outcomes include change in depressive symptoms severity and safety/tolerability measures.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with a diagnosis of major depressive disorder and moderate to severe symptoms can join. You cannot join if you have bipolar disorder, schizophrenia, or other psychotic disorders. Individuals with recent substance use problems or active suicidal thoughts cannot participate. Pregnant or breastfeeding individuals and those with known allergies to the study drugs are excluded. This trial is studying Major Depressive Disorder (MDD), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much depression symptoms improve after 6 weeks of treatment, indicating how well the drugs work to alleviate sadness and other depressive feelings. The specific primary outcome measures are: Change in Depression Severity (measured by HAMD-17) (6 weeks). 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 study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a need for new and potentially more effective treatments for major depressive disorder, a condition affecting millions worldwide. This research targets Major Depressive Disorder (MDD), where improved treatment options are needed.

Investor Insight

This trial explores a novel combination therapy for a large market, potentially offering a new option if proven effective and safe, though it faces competition from established SSRIs and other antidep

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for you and what the potential benefits and risks are. You will take either the study drug or an SSRI for 6 weeks and attend regular assessments. Participation involves regular check-ins to monitor your depression symptoms and overall health. The trial is being conducted at 2 sites. 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

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

Diagnosed with major depressive disorder (MDD) per DSM-5 criteria.

Baseline depression score indicating moderate to severe depression

Ability to provide informed consent

Willing to comply with study requirements

Exclusion Criteria:

History of bipolar disorder, schizophrenia, or other psychotic disorders

Current substance use disorder (within past 6 months)

Active suicidal ideation requiring urgent intervention

Pregnancy or breastfeeding

Known hypersensitivity to study medications

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06957223?

NCT06957223 is a Not Applicable INTERVENTIONAL study titled "Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder." It is currently active, not recruiting and is sponsored by Asad Ullah Jan. The trial targets enrollment of 80 participants.

What conditions does NCT06957223 study?

This trial investigates treatments for Major Depressive Disorder (MDD). The primary condition under study is Major Depressive Disorder (MDD).

What treatments are being tested in NCT06957223?

The interventions being studied include: Dextromethorphan-Bupropion (DRUG), SSRIs (DRUG). Participants will receive a fixed-dose combination of dextromethorphan-bupropion, dosed according to approved guidelines for major depressive disorder, administered orally for 6 weeks.

What does Not Applicable mean for NCT06957223?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06957223?

This trial is currently "Active, Not Recruiting." It started on 2025-05-06. The estimated completion date is 2025-12-31.

Who is sponsoring NCT06957223?

NCT06957223 is sponsored by Asad Ullah Jan. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06957223?

The trial aims to enroll 80 participants. The trial status is active, not recruiting.

How is NCT06957223 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs triple 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 NCT06957223?

The primary outcome measures are: Change in Depression Severity (measured by HAMD-17) (6 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06957223 being conducted?

This trial is being conducted at 2 sites, including Nowshera, KPK (Pakistan).

Where can I find official information about NCT06957223?

The official record for NCT06957223 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06957223. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06957223 testing in simple terms?

This trial tests if a new combination drug (dextromethorphan-bupropion) works better than common antidepressants (SSRIs) for major depression. It's for adults diagnosed with moderate to severe major depressive disorder.

Why is this trial significant?

This trial addresses a need for new and potentially more effective treatments for major depressive disorder, a condition affecting millions worldwide.

What are the potential risks of participating in NCT06957223?

Common side effects may include dizziness, nausea, and dry mouth. There is a risk of allergic reactions to the study medications. As with any antidepressant, there is a small risk of increased suicidal thoughts, especially at the beginning of treatment. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06957223?

Ask your doctor if this trial is a good fit for you and what the potential benefits and risks are. You will take either the study drug or an SSRI for 6 weeks and attend regular assessments. Participation involves regular check-ins to monitor your depression symptoms and overall health. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06957223 signal from an investment perspective?

This trial explores a novel combination therapy for a large market, potentially offering a new option if proven effective and safe, though it faces competition from established SSRIs and other antidep This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will take either the new drug or an SSRI for 6 weeks and have their depression symptoms assessed. 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.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.