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fluoxetine + Amfebutamone
fluoxetine + Amfebutamone is a SSRI + NDRI combination antidepressant Small molecule drug developed by Shanghai Mental Health Center. It is currently FDA-approved for Major depressive disorder, Treatment-resistant depression.
This combination enhances monoamine neurotransmission by inhibiting serotonin reuptake (fluoxetine) and inhibiting norepinephrine and dopamine reuptake (amfebutamone).
This combination enhances monoamine neurotransmission by inhibiting serotonin reuptake (fluoxetine) and inhibiting norepinephrine and dopamine reuptake (amfebutamone). Used for Major depressive disorder, Treatment-resistant depression.
At a glance
| Generic name | fluoxetine + Amfebutamone |
|---|---|
| Sponsor | Shanghai Mental Health Center |
| Drug class | SSRI + NDRI combination antidepressant |
| Target | Serotonin transporter (SERT), norepinephrine transporter (NET), dopamine transporter (DAT) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Mental Health |
| Phase | FDA-approved |
Mechanism of action
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that increases synaptic serotonin levels. Amfebutamone (bupropion) is a norepinephrine-dopamine reuptake inhibitor (NDRI) that increases norepinephrine and dopamine availability. Together, this combination provides broader monoaminergic coverage, potentially enhancing antidepressant efficacy and addressing serotonin-related side effects of SSRIs alone.
Approved indications
- Major depressive disorder
- Treatment-resistant depression
Common side effects
- Nausea
- Insomnia
- Headache
- Dry mouth
- Tremor
- Seizure risk (amfebutamone-related)
Key clinical trials
- Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities (PHASE4)
- Neurobiological and Genomic Predictors of Relapse in Depression
- Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression (PHASE2)
- Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea
- Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities (PHASE4)
- Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
- eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk (PHASE2)
- eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- fluoxetine + Amfebutamone CI brief — competitive landscape report
- fluoxetine + Amfebutamone updates RSS · CI watch RSS
- Shanghai Mental Health Center portfolio CI
Frequently asked questions about fluoxetine + Amfebutamone
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Related
- Drug class: All SSRI + NDRI combination antidepressant drugs
- Target: All drugs targeting Serotonin transporter (SERT), norepinephrine transporter (NET), dopamine transporter (DAT)
- Manufacturer: Shanghai Mental Health Center — full pipeline
- Therapeutic area: All drugs in Psychiatry / Mental Health
- Indication: Drugs for Major depressive disorder
- Indication: Drugs for Treatment-resistant depression
- Compare: fluoxetine + Amfebutamone vs similar drugs
- Pricing: fluoxetine + Amfebutamone cost, discount & access