CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 283 enrolled
Drug / intervention
Lithium Carbonate +1 moredrug
Likely dose
Lithium Carbonate 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00667745
NCT00667745Phase 4Completed
CompareCT.gov

Lithium Use for Bipolar Disorder (LiTMUS): A Randomized Controlled Effectiveness Trial

National Institute of Mental Health (NIMH)·interventional·Posted Apr 28, 2008·Updated Feb 13, 2018

In Brief

A Phase 4 clinical trial evaluating Lithium Carbonate and Optimized Treatment (OPT) for Bipolar Disorder. Completed, enrolled 283 participants across 6 sites.

Detailed Summary

This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 28, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.2 years ago

Interventions

Lithium Carbonatedrug

Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.

Optimized Treatment (OPT)drug

The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.