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List of investigational bipolar disorder drugs

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This is a list of investigational bipolar disorder drugs, or drugs that are currently under development for clinical use for the treatment of bipolar disorder (manic depression) and related conditions but are not yet approved. Bipolar disorder and related conditions include bipolar I disorder, bipolar II disorder, cyclothymia, manic episodes, bipolar depression, and schizoaffective disorder (bipolar/manic and mixed types).

Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in parentheses. The format of list items is "Name (Synonyms) – Mechanism of Action – Indication [Reference]".

This list was last comprehensively updated in May 2026. It is likely to become outdated with time.

Under development

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Preregistration

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  • Lurasidone (DSP-1349M; Latuda; SM-13496; SMP-13496) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders

Phase 3

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  • ALM-008 – undefined mechanism of action (mood stabilizer) – bipolar disorders
  • Azetukalner (1OP-2198; encukalner; VRX-621698; XEN-1101; XPF-008) – Kv7.2 and Kv7.3 potassium channel opener – bipolar depression
  • Brenipatide (LY-3537031) – glucagon-like peptide-1 (GLP-1) receptor agonist and gastric inhibitory polypeptide (GIP) receptor agonist – bipolar disorders
  • Brexpiprazole (Lu-AF41156; OPC-34712; OPDC-34712; Rexulti; Rxulti) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Cycloserine/lurasidone (Cyclurad; D-cycloserine/lurasidone; lurasidone/cycloserine; NRX-101) – combination of cycloserine (ionotropic glutamate NMDA receptor glycine site partial agonist) and lurasidone (atypical antipsychotic/non-selective monoamine receptor modulator) – bipolar depression
  • Endoxifen (4-hydroxy-N-desmethyltamoxifen; Z-endoxifen) – selective estrogen receptor modulator (SERM) and protein kinase C (PKC) inhibitor – bipolar disorders
  • Lumateperone (Caplyta; ITI-007; ITI-722) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Risperidone extended release (LYN-005) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder
  • SEP-4199 (non-racemic amisulpride; aramisulpride/esamisulpride [85:15 ratio]) – dopamine D2 and D3 receptor antagonist and serotonin 5-HT2B and 5-HT7 receptor antagonist – bipolar depression
  • Xanomeline/trospium chloride (BMS-986510; Cobenfy; KarXT; LY-246708/trospium chloride) – combination of xanomeline (non-selective muscarinic acetylcholine receptor agonist) and trospium chloride (peripherally selective non-selective muscarinic acetylcholine receptor antagonist) – bipolar disorders

Phase 2/3

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  • Opakalim (BHV-7000; BPN-25203; KB-3061) – Kv7.2 and Kv7.3 potassium channel opener – bipolar disorders

Phase 2

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  • Aldesleukin (ILT-101; interleukin-2; IL2; IL-2) – recombinant interleukin-2 (IL-2) replacement (interleukin-2 receptor agonist) – bipolar disorders
  • Amdiglurax (ALTO-100; NSI-189) – unknown mechanism of action (hippocampal neurogenesis stimulant and indirect brain-derived neurotrophic factor (BDNF) modulator) – bipolar depression
  • Brilaroxazine (RP-5000; RP-5063) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder
  • Cenobamate (ONO-2017; Ontozry; senovamate; X-Copri; XCopri; YKP-3089) – voltage-gated sodium channel (VGSC) blocker and GABA release enhancer – bipolar disorders
  • Desmethyl cariprazine prodrug (ABBV-932; RGH-932) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression, bipolar disorders
  • Direclidine (HTL-0016878; NBI-1117568; NBI-568) – muscarinic acetylcholine M4 receptor agonist – bipolar I disorders
  • Ebselen (DR-3305; ebselene; ebseleno; ebselenum; harmokisane; PZ-51; SPI-1005; SPI-3005) – various actions – bipolar disorders
  • Elunetirom (ABX-002) – thyroid hormone receptor beta (TRβ) agonist – bipolar depression
  • Icalcaprant (ABBV-1354; CVL-354) – κ-opioid receptor antagonist – bipolar depression
  • JNJ-8942 – undefined mechanism of action – bipolar disorders
  • JNJ-18038683 – serotonin 5-HT7 receptor antagonist – bipolar disorders
  • JNJ-55308942 – purine P2X7 receptor antagonist – bipolar depression
  • Lithium cocrystal (AL-001-Alzamend Neuro; lithium salicylate/L-proline cocrystal) – undefined mechanism of action (mood stabilizer) – bipolar disorders, bipolar I disorders
  • N-Methylamisulpride (LB-102) – dopamine D2 and D3 receptor antagonist and serotonin 5-HT2B and 5-HT7 receptor antagonist – bipolar depression
  • Navacaprant (BTRX-140; BTRX-335140; CYM-53093; NMRA-140; NMRA-335140) – κ-opioid receptor antagonist – bipolar depression
  • OSU-6162 (PNU-9639; PNU-96391; PNU-96391A) – dopamine D2 receptor agonist, serotonin 5-HT2A receptor agonist, and so-called "dopamine stabilizer" – bipolar depression
  • Psilocybin (COMP360; COMP-360) – non-selective serotonin receptor agonist, serotonin 5-HT2A receptor agonist, and psychedelic hallucinogen – bipolar depression
  • RAP-219 – AMPA receptor negative allosteric modulator – bipolar disorders
  • Vortioxetine (Brintellix; LU-AA21004; LuAA 21004; Trintellix; Vortidif) – serotonin reuptake inhibitor, serotonin 5-HT1A and 5-HT1B receptor agonist, and serotonin 5-HT1D, 5-HT3, and 5-HT7 receptor antagonist – bipolar depression
  • Zuranolone (BIIB-125; S-812217; SAGE-217; SGE-797; Zurzuvae) – GABAA receptor positive allosteric modulator and neurosteroid – bipolar depression

Phase 1/2

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  • Cariprazine (cariprazine depot) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders

Phase 1

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  • Brilaroxazine (RP-5000; RP-5063) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • CB03-154 (CB-03; CB-003) – Kv7.2 and Kv7.3 potassium channel opener – bipolar disorders
  • Scopolamine (DPI-385-CVS; DPI-386; DPI-386 Nasal Gel; DPI-386-SG; DPI-386-SS; DPI-387; DPI-521-CG; DPI-550-TBI; Inscop spray) – non-selective muscarinic acetylcholine receptor antagonist – bipolar depression

Clinical phase unknown

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  • LTX-001 – glutaminase inhibitor – bipolar disorders
  • Quetiapine oral suspension – non-selective monoaminer eceptor modulator – bipolar disorders

Research

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  • NORA-520 (NRT-023; brexanolone prodrug) – GABAA receptor positive allosteric modulator and neurosteroid (brexanolone prodrug) – bipolar disorders

Not under development

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No development reported

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  • AMG-581 – undefined mechanism of action – schizoaffective disorder
  • Aripiprazole controlled release (ZY-102) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Aripiprazole transdermal (AQS-1301) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • AZD-4451 – undefined mechanism of action – bipolar disorders
  • Cariprazine (MP-214; Reagila; RGH-188; Symvenu; Vraylar; WID-RGC20) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder
  • Elpetrigine (GW293273; JZP-4) – volgate-gated sodium channel blocker and calcium channel blocker – bipolar disorders
  • Esketamine (Falkieri; PG061; S-ketamine) – ionotropic glutamate NMDA receptor antagonist – bipolar depression
  • Paliperidone controlled-release (DLP-115) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Research programme: long-acting neuropsychiatric therapeutics - Teva (NP-201; NP-202; NP-202-Teva; NP201-Teva; risperidone long-acting implant; ropinirole long-acting implant) – monoamine receptor modulators – bipolar disorders
  • SKL-PSY (FZ-016; SKL-PSY/FZ-016) – serotonin 5-HT1A receptor agonist – bipolar disorders
  • SPD-421 (DP-VPA) – voltage-gated sodium channel (VGSC) blocker, GABA transaminase (GABA-T) inhibitor, histone deacetylase inhibitor, other actions (valproic acid prodrug) – bipolar disorders
  • SPN-802 – undefined mechanism of action – bipolar disorders
  • Ziprasidone extended release (ziprasidone once-daily) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders

Suspended

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  • Uridine (RG-2417) – mitochondrial protein stimulant – bipolar disorders

Discontinued

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  • Armodafinil (CEP-10953; Nuvigil; R-modafinil) – atypical dopamine reuptake inhibitor (DRI) – bipolar depression
  • Bifeprunox (DU-127090) – dopamine D2 and D3 receptor partial agonist and serotonin 5-HT1A receptor partial agonist – bipolar disorders
  • BL-1020 (AN-168; CYP-1020; perphenazine GABA ester; perphenazine-4-aminobutyrate) – dopamine receptor antagonist and GABA receptor agonist – schizoaffective disorder
  • Eslicarbazepine acetate (Aptiom; BIA 2-093; Exalief; SEP-0002093; SEP-2093; Stedesa; Zebinix) – voltage-gated sodium channel (VGSC) blocker (eslicarbazepine prodrug) – bipolar disorders
  • Gabapentin (CI-945; Gabapen; GOE-3450; Neurontin) – gabapentinoid (α2δ voltage-dependent calcium channel blocker) – bipolar disorders
  • Licarbazepine (GP-47779; LIC-477; licarbazapine) – voltage-gated sodium channel (VGSC) blocker
  • Lisdexamfetamine (Elvanse; LDX; NRP-104; S-877489; SHP-489; SPD-489; Tyvense; Venvanse; Vyvanse) – norepinephrine–dopamine releasing agent (NDRA) – bipolar depression
  • Lu AA39959 – ion channel modulator – bipolar depression, bipolar disorders
  • Lu AF35700 – dopamine D1 receptor modulator, serotonin 5-HT2A receptor modulator, and serotonin 5-HT6 receptor modulator – schizoaffective disorder
  • MK-8189 – phosphodiesterase PDE10A inhibitor – bipolar disorders
  • MP-101 (LY-2979165) – metabotropic glutamate mGlu2 and mGlu3 receptor agonist – bipolar disorders
  • Oxcarbazepine (GP-47680; KIN-493; NPC-04; oxacarbazepine; TRI-476; Trileptal) – voltage-gated sodium channel (VGSC) blocker (licarbazepine prodrug) – bipolar disorders
  • Oxcarbazepine extended-release – voltage-gated sodium channel (VGSC) blocker (licarbazepine prodrug) – bipolar disorders
  • Paliperidone (9-hydroxyrisperidone; Invega; JNS-007ER; R0-76477; RO-76477) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders, manic episodes
  • PF-04455242 (PF-4455242) – κ-opioid receptor antagonist – bipolar depression
  • R-103 (ABS-103R; R-ABS-103; (R)-ABS-103) – "GABA receptor agonist" (valproic acid analogue) – bipolar disorders
  • Radafaxine (GW-353162; bupropion metabolite) – norepinephrine–dopamine reuptake inhibitor (NDRI) – bipolar disorders
  • Ralmitaront (NTX-2001; RG-7906; RO-6889450) – trace amine-associated receptor 1 (TAAR1) agonist – schizoaffective disorder
  • Ramelteon (Rozerem; TAK-375; TAK-375SL) – melatonin MT1 and MT2 receptor agonist – bipolar depression, bipolar disorders
  • Rapastinel (BV-102; GLYX-13; GLYX-13-peptide; GLYX-13-trifluoroacetate; TPPT-amide; TPPT-amide-trifluoroacetate) – ionotropic glutamate NMDA receptor glycine site partial agonist – bipolar depression
  • Risperidone (risperidone LAI) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • scyllo-Inositol (AZD-103; ELND-005; quercinitol; scyllitol; scyllocyclohexanehexol; scylloinositol) – undefined mechanism of action – bipolar disorders
  • SEP-378608 – undefined mechanism of action – bipolar disorders
  • SR-31742A (SR-31742) – sigma receptor modulator – manic episodes
  • Topiramate (Epitomax; KW-6485; KW-6485P; MCN 4853; RWJ 17021; Topamax; Topimax; Topina) – various actions – bipolar disorders
  • Vabicaserin (PF-05208769; PF-5208769; SCA-136) – serotonin 5-HT2C receptor agonist – bipolar disorders
  • Vixotrigine (BIIB-074; CNV-1014802; GSK-1014802; raxatrigine) – Nav1.7 voltage-gated sodium channel (VGSC) blocker – bipolar disorders
  • Vofopitant (GR-205171) – neurokinin NK1 receptor antagonist – bipolar disorders
  • Ziprasidone (CP-88059-01; CP-88059-1; Geodon; ME-2112; RQ-00000003; Zeldox) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression
  • Zonisamide (AD-810; AD-810N; CI-912; Excegran; Kinaplase; PD-110843; Tremode; Trerief; Zonegran) – various actions – manic episodes

Clinically used drugs

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Approved drugs

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Atypical antipsychotics

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  • Aripiprazole (Abilify; Abilify Asimtufii; Abilify Maintena; Abilify MyCite; Abilitat; Ao Pai; Arlemide; Asimtufii; OPC-14597; OPC-14597 IMD; OPC-31) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Asenapine (Atisenap; ME2136; ORG-5222; Saphris; SCH-900274; Sycrest) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Cariprazine (MP-214; Reagila; RGH-188; Symvenu; Vraylar; WID-RGC20) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression, bipolar disorders
  • Iloperidone (Fanapt; Fanaptum; Fiapta; HP-873; ILO-522; VYV-683; Zomaril) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Lumateperone (Caplyta; ITI-007; ITI-722) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression
  • Lurasidone (DSP-1349M; Latuda; SM-13496; SMP-13496) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression
  • Milsaperidone (Bysanti; P-88; VHX-869; VHX-896) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Olanzapine (BR-5402; LY-170053; LY-170052; Midax; Zypadhera; Zyprexa; Zyprexa Relprevv; Zyprexa Velotab; Zyprexa Zydis) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression, bipolar disorders, manic episodes
  • Paliperidone (9-hydroxyrisperidone; Invega; JNS-007ER; R0-76477; RO-76477) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder
  • Paliperidone palmitate (Erzofri; LY-03010; Meibirui; Ruibailai) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder
  • Paliperidone palmitate (Byannli; Invega Hafyera; Invega Sustenna; Invega Trinza; RO-92670; Sustenna; Trevicta; Xeplion) – atypical antipsychotic (non-selective monoamine receptor modulator) – schizoaffective disorder
  • Quetiapine (FK-949; FK949E; ICI-204636; Seroquel; Seroquel XL; Seroquel XR) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar depression, bipolar disorders, manic episodes
  • Risperidone (JNJ-410397-AAA; R-64766; R064766; Risperdal; Risperdal Consta; Risperdal Depot) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Risperidone extended release (LY-03004; Rykindo) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Risperidone long-acting injectable (Longavo; mdc-IRM; TEV-46000; TV-46000; Uzedy) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders
  • Ziprasidone (CP-88059-01; CP-88059-1; Geodon; ME-2112; RQ-00000003; Zeldox) – atypical antipsychotic (non-selective monoamine receptor modulator) – bipolar disorders

Anticonvulsants

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  • Lamotrigine (430C78; BW-430C; Labileno; Lamactil; Lamictal; Lamictin; Lamitrin) – volgate-gated sodium channel (VGSC) blocker – bipolar disorders
  • Lamotrigine oral suspension (Subvenite) – volgate-gated sodium channel (VGSC) blocker – bipolar disorders
  • Lamotrigine orally disintegrating tablet (EUR-1048; Lamictal ODT; lamotrigine ODT) – voltage-gated sodium channel (VGSC) blocker – bipolar disorders
  • Valproate semisodium (sodium valproate; Depakote; Depakote ER; divalproex; divalproex sodium; Epival; Epival ER; LA40220) – voltage-gated sodium channel (VGSC) blocker, GABA transaminase (GABA-T) inhibitor, histone deacetylase inhibitor, other actions – bipolar disorders
  • Valproic acid oral (Stavzor; Stavzor ER) – voltage-gated sodium channel (VGSC) blocker, GABA transaminase (GABA-T) inhibitor, histone deacetylase inhibitor, other actions – bipolar disorders

Lithium salts

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  • Lithium carbonate (Eskalith, Eskalith CR, Lithane, Lithonate, Lithobid) – unknown mechanism of action (mood stabilizer) – manic episodes [1]
  • Lithium citrate (Cibalith-S, Litarex, Lithonate, Priadel) – unknown mechanism of action (mood stabilizer) – manic episodes [1]
  • Lithium sulphate (lithium sulfate; Lithionit) – unknown mechanism of action (mood stabilizer) – manic episodes

Combination drugs

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  • Olanzapine/fluoxetine (OFC; Symbyax; ZypZac) – combination of olanzapine (atypical antipsychotic/non-selective monoamine receptor modulator) and fluoxetine (selective serotonin reuptake inhibitor) – bipolar disorders
  • Olanzapine/samidorphan (ALKS-33/olanzapine; ALKS-3831; Lybalvi) – combination of olanzapine (atypical antipsychotic/non-selective monoamine receptor modulator) and samidorphan (non-selective opioid receptor antagonist) – bipolar disorders

Off-label drugs

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See also

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References

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  1. 1 2 "Drugs@FDA: FDA-Approved Drugs". accessdata.fda.gov. Retrieved 3 June 2026.
  2. 1 2 Citrome L, Correll CU, San L, Zeller SL, Madden S, Gutierrez J, Lopez-Toledano M, Misra SN, Carrazana E, Rabinowicz AL (January 2024). "Alternative Approaches for Addressing Acute Agitation in Schizophrenia and Bipolar Disorder". Prim Care Companion CNS Disord. 26 (1). doi:10.4088/PCC.23nr03596. PMID 38301034.
  3. ↑ Smith CM, Santalucia M, Bunn H, Muzyk A (May 2023). "Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder". Clin Psychopharmacol Neurosci. 21 (2): 215–221. doi:10.9758/cpn.2023.21.2.215. PMC 10157019. PMID 37119214.
  4. ↑ Karlin DM, Nelson LA, Campbell AR (January 2024). "Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders". Ann Pharmacother. 58 (1): 54–64. doi:10.1177/10600280231171179. PMID 37119212.
  5. ↑ Singal P, Nuñez NA, Joseph B, Hassett LC, Seshadri A, Singh B (March 2023). "Efficacy and Safety of Clonidine in the Treatment of Acute Mania in Bipolar Disorder: A Systematic Review". Brain Sci. 13 (4): 547. doi:10.3390/brainsci13040547. PMC 10137105. PMID 37190511.
  6. ↑ Rosa AR, Fountoulakis K, Siamouli M, Gonda X, Vieta E (June 2011). "Is anticonvulsant treatment of mania a class effect? Data from randomized clinical trials". CNS Neurosci Ther. 17 (3): 167–177. doi:10.1111/j.1755-5949.2009.00089.x. PMC 6493801. PMID 20015083.
  7. ↑ Yatham LN (2004). "Newer anticonvulsants in the treatment of bipolar disorder". J Clin Psychiatry. 65 Suppl 10: 28–35. PMID 15242330.
  8. ↑ Kessing LV (October 2025). "The use of antidepressants for bipolar disorder - a controversy between science and clinical practice". Dan Med J. 72 (12): 1–9. doi:10.61409/A07250539. PMID 41312697.
  9. ↑ Tohen M, Vieta E (June 2009). "Antipsychotic agents in the treatment of bipolar mania". Bipolar Disord. 11 Suppl 2: 45–54. doi:10.1111/j.1399-5618.2009.00710.x. PMID 19538685.
  10. ↑ Pacchiarotti I, Anmella G, Colomer L, Vieta E (September 2020). "How to treat mania". Acta Psychiatr Scand. 142 (3): 173–192. doi:10.1111/acps.13209. PMID 33460070.
  11. ↑ Hirschowitz J, Kolevzon A, Garakani A (2010). "The pharmacological treatment of bipolar disorder: the question of modern advances". Harv Rev Psychiatry. 18 (5): 266–278. doi:10.3109/10673229.2010.507042. PMID 20825264.
  12. ↑ Gefke M, Wagner CB, McIntyre RS, Vinberg M (January 2026). "The Potential Clinical Use of Opioid-Receptor-Modulating Drugs in Bipolar Disorder". CNS Drugs. 40 (1): 59–70. doi:10.1007/s40263-025-01247-8. PMID 41222827.
  13. ↑ Carlezon WA, Béguin C, Knoll AT, Cohen BM (September 2009). "Kappa-opioid ligands in the study and treatment of mood disorders". Pharmacol Ther. 123 (3): 334–343. doi:10.1016/j.pharmthera.2009.05.008. PMC 2740476. PMID 19497337.
  14. ↑ Cohen BM, Murphy B (March 2008). "The effects of pentazocine, a kappa agonist, in patients with mania". Int J Neuropsychopharmacol. 11 (2): 243–247. doi:10.1017/S1461145707008073. PMID 17897484.
  15. ↑ Palacios J, Yildiz A, Young AH, Taylor MJ (February 2019). "Tamoxifen for bipolar disorder: Systematic review and meta-analysis". J Psychopharmacol. 33 (2): 177–184. doi:10.1177/0269881118822167. PMID 30741085.
  16. ↑ Talaei A, Pourgholami M, Khatibi-Moghadam H, Faridhosseini F, Farhoudi F, Askari-Noghani A, Sadeghi R (June 2016). "Tamoxifen: A Protein Kinase C Inhibitor to Treat Mania: A Systematic Review and Meta-Analysis of Randomized, Placebo-Controlled Trials". J Clin Psychopharmacol. 36 (3): 272–275. doi:10.1097/JCP.0000000000000492. PMID 27088436.
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