NCT03811860

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

January 10, 2019

Last Update Submit

March 6, 2019

Conditions

Bipolar DisorderMajor Depressive Disorder

Keywords

lithiumpharmacokineticsrenalkidney

Outcome Measures

Primary Outcomes (1)

  • Difference in lithium levels between once and twice daily dosing

    The average of the difference in 12 hour post-dose serum level between the two dosing regimens (once daily and twice daily dosing)

    once 2 steady state levels have been taken (4-12 days of intervention)

Secondary Outcomes (2)

  • Correlation between renal function and difference in lithium level

    once 2 steady state levels have been taken (4-12 days of intervention) and average creatinine clearance has been calculated

  • Frequency of selected concurrent medication use

    recorded upon enrollment, and every 4-6 days until study completion, up to 12 months

Study Arms (2)

Once Daily Dosing

ACTIVE COMPARATOR

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.

Diagnostic Test: Lithium levelDiagnostic Test: Serum Creatinine

Twice Daily Dosing

ACTIVE COMPARATOR

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.

Diagnostic Test: Lithium levelDiagnostic Test: Serum Creatinine

Interventions

Lithium levelDIAGNOSTIC_TEST

The level of lithium in the serum

Once Daily DosingTwice Daily Dosing
Serum CreatinineDIAGNOSTIC_TEST

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

Once Daily DosingTwice Daily Dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDepressive Disorder

Central Study Contacts

Virginia Fernandes, PharmD

CONTACT

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

Dario A Moscoso, PharmD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Practice Leader, Psychiatry

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 22, 2019

Study Start

February 6, 2019

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

There is no such plan

Locations

CA(1)