NCT07664852 Pramipexole Dihydrochloride Bipolar Disorder Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07664852 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 4 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07664852 is a hot trial to watch
Bipolar Disorder is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07664852 is notable because it evaluates Pramipexole Dihydrochloride in a Phase 3 design sponsored by Region Skåne Holding AB. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07664852 |
| Official title | Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression (B-HAPPI) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Pramipexole Dihydrochloride |
| Sponsor | Region Skåne Holding AB |
| Geography | Sweden |
| Enrollment | [object Object] |
| Primary endpoint | Change in Snaith-Hamilton Pleasure Scale (SHAPS) self-reported total score after 6 weeks of treatment compared to baseline |
| Endpoint time frame | Between baseline visit and week 6 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of suicide. B-HAPPI is an academic randomized controlled trial to evaluate a new medication for bipolar depression. It will investigate the efficacy and safety of pramipexole, a potent dopamine agonist that has demonstrated significant effectiveness in bipolar disorder in preliminary studies, showing large effect sizes. * Population: 126 patients with bipolar depression * Intervention: Pramipexole added to ongoing treatment with mood stabilizer, flexible dosing - target dose 2.1 mg/day * Control: Add-on identical placebo * Outcomes: Primary outcome is change in anhedonia symptoms between baseline and 6 weeks of intervention. Key secondary outcomes include (for example) general depression symptoms and safety measures.
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Sweden shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) self-reported total score after 6 weeks of treatment compared to baseline (Between baseline visit and week 6) — 14 items rated from points with 1 to 4. Higher scores equal more severe anhedonia. Score range: 14-56.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Pramipexole Dihydrochloride is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Region Skåne Holding AB is resolved to a normalized organization record in Sweden. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07664852 provides a focused lens on Bipolar Disorder development. Its value will be determined by whether Pramipexole Dihydrochloride can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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