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NCT04315792
Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
Phase 3 trial testing Endoxifen in Bipolar I Disorder in 124 participants. Completed in 25 August 2021.
25 January 2021
Quick facts
| Lead sponsor | Jina Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 3 August 2020 |
| Primary completion | 25 January 2021 |
| Estimated completion | 25 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Endoxifen — full drug profile →
- Placebo oral tablet — full drug profile →
Conditions studied
- Bipolar I Disorder — all drugs for Bipolar I Disorder →
Sponsor
Jina Pharmaceuticals Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Bipolar I Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study results. More so given the risks to patients and their communities from a medication whose efficacy has not been thoroughly evaluated against a placebo control. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Existing and emerging pharmacological approaches to the treatment of mania: A critical overview.
Sparacino G, Verdolini N, Vieta E, Pacchiarotti I. · · 2022 · cited 4× · PMID 35461339 · DOI 10.1038/s41398-022-01928-8
Verify or expand the search:
- PubMed search for NCT04315792
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT05427123 — Children's Bipolar Network Treatment Trial I · recruiting
Other Jina Pharmaceuticals Inc. trials
Trials by the same sponsor.
- NCT03671044 — A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Pat · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04315792 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jina Pharmaceuticals Inc.
- Last refreshed: 23 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04315792.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing