Real-world Lithium Intake

Condition(s) studied

Investigational drug(s) / intervention(s)

Lithium (LI) based on clinical indication: Participants have for 4 weeks a pill box registering the time for lithium intake. Weekly phone calls will assess whether patients can remember the time for lithium intake.

Study summary

The aim of the present study is to study compliance with lithium therapy and patterns of lithium intake among a representative group of patients with bipolar disorder in a real-world clinical setting. This will be studied via a pill box that registers the daily time when the participant took the lithium tablet out of the pill box, representing a proxy for the actual lithium intake. Participants will receive a weekly phone call asking for several aspects of lithium intake.

Eligibility

Primary outcome measure(s)

• Compliance with lithium therapy — From enrollment for 4 weeks
  Study if patients take their lithium medication on a daily basis, which is measured via a pillbox that registers the time for lithium intake (used for 4 weeks by each participant)
• Regular intake — From enrollment for 4 weeks
  Study whether lithium-treated patients take their lithium medication at the same time of day, meaning within 30 minutes of the same time point (measured for 4 weeks via a pillbox containing the lithium medication)
• The mean time in minutes between the self-reported time for intake of the most recent lithium dose (mentioned at the weekly phone call) and the registered time for the actual intake of the most recent lithium dose (i.e., the most recent intake of lithium — From enrollment for 4 weeks
• If a larger deviation between the self-reported and the registered time for lithium intake (i.e. the measure from co-primary outcome 3) depends on if participants are in a (hypo)manic or depressive mood state (which is answered at the weekly phone call). — From enrollment for 4 weeks

Trial sites (1)

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