Last reviewed 2026-04-22 · How we verify

Paroxetine+Lithium

Paroxetine+Lithium is a SSRI + mood stabilizer combination Small molecule drug developed by Ministry of Health & Welfare, Korea. It is currently FDA-approved for Major depressive disorder, particularly treatment-resistant depression, Bipolar disorder depression. Also known as: seroxat, lithan.

Paroxetine inhibits serotonin reuptake while lithium modulates intracellular signaling and mood stabilization, together enhancing antidepressant and mood-stabilizing effects.

Paroxetine inhibits serotonin reuptake while lithium modulates intracellular signaling and neurotransmitter activity, together enhancing serotonergic neurotransmission for mood stabilization. Used for Major depressive disorder, Bipolar disorder (depression phase), Treatment-resistant depression.

At a glance

Mechanism of action

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) that increases synaptic serotonin by blocking its reuptake at the presynaptic membrane. Lithium acts as a mood stabilizer by inhibiting inositol monophosphatase and affecting intracellular signaling cascades, particularly protein kinase C and glycogen synthase kinase-3 pathways. The combination is used to augment antidepressant efficacy and provide mood stabilization in treatment-resistant depression and bipolar disorder.

Approved indications

• Major depressive disorder, particularly treatment-resistant depression
• Bipolar disorder depression

Common side effects

• Nausea
• Tremor
• Diarrhea
• Headache
• Sexual dysfunction
• Polyuria/polydipsia
• Weight gain
• Thyroid dysfunction

Key clinical trials

• The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients (PHASE1, PHASE2)
• Lithium Versus Paroxetine in Major Depression (PHASE4)
• Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders (NA)
• Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
• Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide (PHASE3)
• Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
• Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients (PHASE4)
• Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Paroxetine+Lithium CI brief — competitive landscape report
• Paroxetine+Lithium updates RSS · CI watch RSS
• Ministry of Health & Welfare, Korea portfolio CI

Frequently asked questions about Paroxetine+Lithium

Related

• Drug class: All SSRI + mood stabilizer combination drugs
• Target: All drugs targeting Serotonin transporter (SERT); inositol monophosphatase; protein kinase C
• Manufacturer: Ministry of Health & Welfare, Korea — full pipeline
• Therapeutic area: All drugs in Psychiatry
• Indication: Drugs for Major depressive disorder, particularly treatment-resistant depression
• Indication: Drugs for Bipolar disorder depression
• Also known as: seroxat, lithan

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing