Recruiting

Lithium

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT03811860

Conditions

Bipolar Disorder

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lithium level

Serum Creatinine

Study Details

Brief 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.

Conditions

Bipolar Disorder

Major Depressive Disorder

Study ID

NCT03811860

Start date

Feb 6, 2019

Status verified date

Mar, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • any patients who are currently pregnant
  • patients taking lithium three times daily
  • patients taking lithium with a specific dosing frequency for a documented clinical reason.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Once Daily Dosing

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.

active comparator: Twice Daily Dosing

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.

Interventions

Lithium level

The level of lithium in the serum

Serum Creatinine

The level of creatinine (as an indicator of kidney function, to approximate GFR) in the serum

Primary outcome measure

  • Difference in lithium levels between once and twice daily dosing [ Time Frame: once 2 steady state levels have been taken (4-12 days of intervention) ]

Central Contacts and Locations

Central contacts

Virginia Fernandes, PharmD

416-586-4800virginia.fernandes@sinaihealthsystem.ca

Dario A Moscoso, PharmD

416-586-4800dario.moscoso@sinaihealthsystem.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Mar 8, 2019

Last verified

Mar, 2019

Keywords

  • lithium
  • pharmacokinetics
  • renal
  • kidney

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2019-03-08.