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Lithium or Valproate with Aripiprazole
Aripiprazole acts as a dopamine D2/D3 receptor partial agonist and serotonin 5-HT1A partial agonist, while lithium and valproate modulate intracellular signaling and gene expression to enhance mood stabilization and reduce manic/depressive symptoms.
Aripiprazole acts as a dopamine D2/D3 receptor partial agonist and serotonin 5-HT1A partial agonist, while lithium and valproate modulate intracellular signaling and gene expression to enhance mood stabilization and reduce manic/depressive episodes. Used for Bipolar I disorder, acute manic or mixed episodes, Bipolar disorder maintenance treatment.
At a glance
| Generic name | Lithium or Valproate with Aripiprazole |
|---|---|
| Also known as | Abilify, BMS-337039 |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Atypical antipsychotic combined with mood stabilizers |
| Target | Dopamine D2/D3 receptors, serotonin 5-HT1A receptor (aripiprazole); inositol monophosphatase, GSK-3 (lithium); histone deacetylase (valproate) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Aripiprazole's partial agonism at dopamine and serotonin receptors helps normalize neurotransmitter activity in psychotic and mood disorders. Lithium inhibits inositol monophosphatase and glycogen synthase kinase-3 (GSK-3), affecting intracellular signaling cascades critical for mood regulation. Valproate increases GABA levels and inhibits histone deacetylase, promoting neuroprotection and mood stabilization. The combination leverages complementary mechanisms for enhanced efficacy in bipolar disorder.
Approved indications
- Bipolar I disorder, acute manic or mixed episodes
- Bipolar disorder maintenance treatment
Common side effects
- Akathisia
- Tremor
- Weight gain
- Sedation
- Nausea
- Headache
- Diarrhea (valproate)
- Polyuria/polydipsia (lithium)
Key clinical trials
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania (PHASE4)
- Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder (PHASE3)
- Study of Aripiprazole in Patients With Bipolar I Disorder (PHASE3)
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 |
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