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NCT04945057: VAL1M
AKTIBIPO-VALIDATION: A Study to Validate Benefits of Mindpax System in Managing Bipolar Disorder
NA trial testing Mindpax monitoring system in Bipolar Disorder in 130 participants. Status unknown.
31 October 2023
Quick facts
| Lead sponsor | National Institute of Mental Health, Czech Republic |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 130 |
| Start date | 5 May 2021 |
| Primary completion | 31 October 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Mindpax monitoring system
Conditions studied
- Bipolar Disorder — all drugs for Bipolar Disorder →
Sponsor
National Institute of Mental Health, Czech Republic
Who can join
Adults 18 to 65, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the AKTIBIPO VALIDATION study is to evaluate the effect of the Mindpax monitoring and microeducation system in patients with bipolar disorder (BD). Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study, as well as new patients (DeNovo) will be enrolled for a follow-up period of 12 months. All participants will wear the wrist actigraphy device and use the Mindpax mobile application on their mobile phone. Through the application, the patients will fill in the weekly mood self assessment questionnaire (ASERT) and receive evidence-based health microeducations aimed at understanding the bipolar disorder and associated risk factors. Apart from general psychoeducation, the participants will receive additional individualized targeted health microeducation when the system detects deviation from individual patterns of mood, activity and sleep. The outcomes will evaluate the subjective and objective impact of system usage on self-reported and clinical outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04945057
- Europe PMC full search
- ASCO Meeting Library
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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 NCT04945057 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Mental Health, Czech Republic
- Last refreshed: 17 October 2022
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/NCT04945057.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing