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Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder

Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder - Kyoto tOyooka Nested cOntrolled Trial Of RemInders (KONOTORI) Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033633
Enrollment
120
Registered
2018-10-01
Start date
2018-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder and major depressive disorder

Interventions

Reminders of blood test of serum lithium levels per every 6 months Standard care

Sponsors

Graduate School of Medicine and Public Health, Kyoto University
Lead Sponsor
Toyooka Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Bipolar disorder or major depressive disorder according to DSM-5 2) Taking lithium carbonate longer than six months 3) Need to continue lithium carbonate over 18 months (as judged by treating psychiatrist)

Exclusion criteria

Exclusion criteria: 1) Prescribed lithium for a condition other than mood disorder 2) Who did not provide written informed consent 3) Schizophrenia 4) Inappropriate/unable to participate in the trial (as judged by treating psychiatrist) 5) Serious suicide intent (as judged by treating psychiatrist) 6) Lithium intoxication 7) Pregnancy 8) Researcher of the trial and their family 9) Who cannot read Japanese 10) Contraindication of lithium 11) Participation in another clinical trial 12) Inpatients 13) End-stage physical disease 14) Who did not have serum lithium level measurement at baseline 15) Who did not visit hospital between 4-8 months after inclusion

Design outcomes

Primary

MeasureTime frame
The proportion of patients with serum lithium level between 0.4 and 1.0 mEq/l between 18 and 24 months after inclusion

Secondary

MeasureTime frame
1) Number of tests of serum lithium level within 18-24 months after inclusion 2) Exacerbation of mood disorder including admission, a dose increase of lithium, an addition of antipsychotics, antidepressants or mood stabilizers 3) The proportion of days when lithium was prescribed during the study period

Countries

Japan

Contacts

Public ContactTomotsugu Seki

Graduate School of Medical Science, Kyoto Prefectural University of Medicine Department of Cardiovascular Medicine

tseki@koto.kpu-m.ac.jp075-251-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026