What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs (e.g., fluoxetine, escitalopram), SNRIs (e.g., duloxetine, venlafaxine), tricyclic antidepressants (e.g., amitriptyline, imipramine), and atypical antidepressants (e.g., bupropion), are associated with a range of side effects. SSRIs and SNRIs often cause nausea, insomnia, dizziness, dry mouth, and sexual dysfunction. Tricyclic antidepressants can lead to weight gain, sedation, dry mouth, blurred vision, constipation, and urinary retention. Atypical antidepressants like bupropion may cause insomnia, dry mouth, and increased risk of seizures. It is important to discuss these potential side effects with a healthcare provider to tailor treatment to individual needs and tolerances.

What prior FDA approvals exist?

The FDA has approved several classes of antidepressants for the treatment of depression. Selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, and escitalopram are commonly used due to their efficacy and tolerability. Serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine and duloxetine are also approved and effective, particularly for patients who do not respond to SSRIs. Tricyclic antidepressants (TCAs) such as imipramine and amitriptyline, though older, are still used in certain cases. Additionally, atypical antidepressants like bupropion and mirtazapine offer alternative mechanisms of action. These medications have been studied extensively and are foundational in the pharmacological treatment of depression.

What other types of research exist?

Promising novel alternatives for depression treatment in 2024 include: 1) Bupropion Hydrobromide, which has shown efficacy and safety in adolescents and children with major depressive disorder in a double-blind, placebo-controlled, multicenter study. 2) Transcranial Magnetic Stimulation (TMS), which is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain and has been used for treatment-resistant depression. 3) Ketamine and Esketamine, which are rapid-acting antidepressants that have shown promise in treating major depressive disorder, particularly in treatment-resistant cases. 4) Psychedelic-assisted therapy, including the use of substances like psilocybin, which is being studied for its potential to provide rapid and sustained antidepressant effects. These treatments represent some of the most promising novel alternatives for depression patients considering treatment in 2024.

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Antidepressant

Bupropion for Depression

Phase 4

Waitlist Available

Research Sponsored by Bausch Health Americas, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1)

Be younger than 18 years old

Must not have

Body weight less than the 3rd percentile or greater than the 97th percentile for age

ECG or physical examination abnormality at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 2 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests a new treatment for children with depression. The effectiveness is measured by changes in depression symptoms. Fluoxetine has been shown to be effective in treating major depressive disorder in children and adolescents.

Who is the study for?

This trial is for boys and girls aged 7 to under 18 with Major Depressive Disorder (MDD), as defined by the DSM IV-TR, experiencing a depressive episode lasting at least 4 weeks. They must have specific scores on depression rating scales and give consent along with their parents. It's not for those who've attempted suicide, have certain medical conditions or abnormal ECGs, are outside the normal weight range for their age, pregnant or breastfeeding, or have seizure disorders.

What is being tested?

The study tests Bupropion Hydrobromide's effectiveness and safety in treating children and adolescents' depression compared to a placebo. Participants won't know which treatment they're getting in this double-blind study conducted across multiple centers.

What are the potential side effects?

Bupropion Hydrobromide may cause headaches, stomach pain, sleep disturbances, agitation or anxiety; more rarely seizures. Side effects can vary widely between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been experiencing a depressive episode for at least 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My body weight is within the normal range for my age.

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My heart test or physical exam showed something unusual.

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I have trouble swallowing pills.

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I have a history of seizures or head trauma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change from Baseline to EOT in total CDRS-R (raw) score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: bupropion hydrobromideExperimental Treatment1 Intervention

study drug

Group II: placeboPlacebo Group1 Intervention

placebo

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for depression include pharmacotherapy, such as selective serotonin reuptake inhibitors (SSRIs), and psychotherapy, such as cognitive-behavioral therapy (CBT). SSRIs work by increasing the levels of serotonin in the brain, which can help improve mood and emotional stability. CBT helps patients identify and change negative thought patterns and behaviors that contribute to their depression. Exercise is also recommended as it can enhance mood through the release of endorphins and improve overall physical health. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage their expectations regarding the outcomes.

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