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Mood Stabilizer

Once Daily Dosing for Bipolar Disorder

N/A
Waitlist Available
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients admitted to the inpatient psychiatry unit at Mount Sinai Hospital treated with lithium therapy (i.e. taking lithium before admission, or initiated on lithium therapy during hospitalization)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded upon enrollment, and every 4-6 days until study completion, up to 12 months
Awards & highlights

Study Summary

Lithium is a mainstay in the treatment of bipolar disorder, and a frequently used adjunctive therapy for major depressive disorder. It is accepted practice to monitor lithium serum levels to monitor for efficacy and toxicity. However, studies on the difference in lithium levels between once and twice daily dosing, which also assess the impact of kidney function are scarce. The aim of this study is to quantify this pharmacokinetic difference, identify the impact of kidney function, in the context of estimating effects to inform feasibility and sample size needed for a larger well-powered study.

Eligible Conditions
  • Bipolar Disorder
  • Depression

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded upon enrollment, and every 4-6 days until study completion, up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded upon enrollment, and every 4-6 days until study completion, up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in lithium levels between once and twice daily dosing
Secondary outcome measures
Correlation between renal function and difference in lithium level
Frequency of selected concurrent medication use

Trial Design

2Treatment groups
Active Control
Group I: Once Daily DosingActive Control2 Interventions
In this arm of the study, participants receive the prescribed dose of lithium once daily at bedtime. After 4-6 days, a steady state lithium serum level and serum creatinine are taken, and they crossover to the other arm (twice daily dosing, if they have not already done so). Frequency of selected medication use is noted.
Group II: Twice Daily DosingActive Control2 Interventions
In this arm of the study, participants receive the prescribed dose of lithium divided into two daily doses. After 4-6 days a steady state lithium serum level and serum creatinine are taken, and they crossover to the other arm (once daily dosing, if they have not already done so).Frequency of selected medication use is noted.

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,593 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Lithium Therapeutic Drug Monitoring; Once Daily Vs Twice Daily Dosing and the Impact of Kidney Function
Virginia Fernandes 2019. "Lithium Therapeutic Drug Monitoring; Once Daily Vs Twice Daily Dosing and the Impact of Kidney Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03811860.
~2 spots leftby Apr 2025
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