Summary
Topiramate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Bipolar Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Bipolar Disorder. ClinicalTrials.gov lists 8 registered trials linking Topiramate to Bipolar Disorder: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01000402). The largest enrolment is 434 participants (NCT00037674). Registration activity spans 2000 to 2026. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2007 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Bipolar Disorder ranks 389 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Natural episodic pattern: untreated, median episode length 3-6 months; recurrence in 90% within 5 years; functional impairment between episodes in 30-60%; suicide risk 20-30x general population.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor; inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | CA4 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00572117 | Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder 2007 | completed | Phase 4 | 12 |
| NCT07213466 | Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder 2026 | recruiting | Phase 4 | 100 |
| NCT01000402 | Juvenile Bipolar Disorder Outpatient Program 2008 | status unknown | Phase 4 | 150 |
| NCT00035802 | A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder 2002 | completed | Phase 3 | 13 |
| NCT00035230 | A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder 2001 | completed | Phase 3 | 338 |
| NCT00037674 | A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder 2001 | completed | Phase 3 | 434 |
| NCT00240721 | A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder 2000 | completed | Phase 3 | 363 |
| NCT00986336 | A Pharmacokinetic Study of Risperidone and Topiramate Administered Alone and in Combination in Patients With Bipolar Disorder or Schizoaffective Disorders 2001 | completed | Phase 1 | 56 |
Published literature
- Cochrane review Therapeutic Overlap Between Bipolar Disorder and Migraine: A Systematic Review of Pharmacological TrialsHaddad M, Dieckmann LHJ, Rodrigues da Silva N et al. · Pharmaceuticals (Basel, Switzerland) · 2026 · PMID 42356466
- Meta-analysis Systematic Review and Network Meta-Analysis: Efficacy and Safety of Antipsychotics vs Antiepileptics or Lithium for Acute Mania in Children and AdolescentsVita G, Nöhles VB, Ostuzzi G et al. · Journal of the American Academy of Child and Adolescent Psychiatry · 2025 · PMID 39128561
- Clinical trial publication A Double-Blind Placebo-Controlled Pilot Study of Topiramate in Manic Adolescents Treated with OlanzapineDelBello MP, Bruns KM, Bloom T et al. · Journal of child and adolescent psychopharmacology · 2023 · PMID 37130314
- Cochrane review Randomised controlled trials of mood stabilisers for people with autism spectrum disorder: systematic review and meta-analysisLimbu B, Deb S, Roy M et al. · BJPsych open · 2022 · PMID 35197135
- Systematic review What not to use in bipolar disorders: A systematic review of non-recommended treatments in clinical practice guidelinesGomes FA, Cerqueira RO, Lee Y et al. · Journal of affective disorders · 2022 · PMID 34758372
- Cochrane review Pharmacological Treatment for Comorbid Bipolar Disorder and Obsessive-Compulsive Disorder in AdultsNetto VM, Flores CA, Pallanti S · Journal of psychiatric practice · 2020 · PMID 32936585
- Cochrane review Influence of the use of atypical antipsychotics in metabolic syndromeDoménech-Matamoros P · Revista espanola de sanidad penitenciaria · 2020 · PMID 32697278
- Cochrane review Lithium for acute maniaMcKnight RF, de La Motte de Broöns de Vauvert SJGN, Chesney E et al. · The Cochrane database of systematic reviews · 2019 · PMID 31152444
- Systematic review Adverse outcomes during pregnancy and major congenital malformations in infants of patients with bipolar and schizoaffective disorders treated with antiepileptic drugs: A systematic reviewGiménez A, Pacchiarotti I, Gil J et al. · Psychiatria polska · 2019 · PMID 31317955
- Meta-analysis [The use of anticonvulsants and the levels of folate, vitamin B12 and homocysteine]Dinç D, Schulte PFJ · Tijdschrift voor psychiatrie · 2018 · PMID 29341053
- Clinical trial publication A randomized, placebo-controlled proof-of-concept trial of adjunctive topiramate for alcohol use disorders in bipolar disorderSylvia LG, Gold AK, Stange JP et al. · The American journal on addictions · 2016 · PMID 26894822
- Clinical trial publication Topiramate as an adjuvant treatment for obsessive compulsive symptoms in patients with bipolar disorder: a randomized double blind placebo controlled clinical trialSahraian A, Bigdeli M, Ghanizadeh A et al. · Journal of affective disorders · 2014 · PMID 25012432
- Meta-analysis Pharmacologic and behavioral interventions to improve cardiovascular risk factors in adults with serious mental illness: a systematic review and meta-analysisGierisch JM, Nieuwsma JA, Bradford DW et al. · The Journal of clinical psychiatry · 2014 · PMID 24922495
- Clinical trial publication Comparison of open-label, 8-week trials of olanzapine monotherapy and topiramate augmentation of olanzapine for the treatment of pediatric bipolar disorderWozniak J, Mick E, Waxmonsky J et al. · Journal of child and adolescent psychopharmacology · 2009 · PMID 19877978
- Clinical trial publication A 24-week, randomized, controlled trial of adjunctive sibutramine versus topiramate in the treatment of weight gain in overweight or obese patients with bipolar disordersMcElroy SL, Frye MA, Altshuler LL et al. · Bipolar disorders · 2007 · PMID 17547588
Mechanism and notes
Recorded mechanism or class: inhibitor; inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CA4. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Topiramate approved for Bipolar Disorder?
Topiramate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Bipolar Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Bipolar Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Topiramate in clinical trials for Bipolar Disorder?
ClinicalTrials.gov lists 8 registered trials linking Topiramate to Bipolar Disorder: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01000402). The largest enrolment is 434 participants (NCT00037674). Registration activity spans 2000 to 2026.
What does the evidence show for Topiramate in Bipolar Disorder?
Topiramate has both completed registered trials and synthesis-level publications linked to Bipolar Disorder. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CA4. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.