CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 224 enrolled
Drug / intervention
Lithium (LI) +1 moredrug
Likely dose
Lithium (LI) 150 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/NCT00254488
NCT00254488Phase 4Completed
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Acute Pharmacotherapy of Late-Life Mania (GERI-BD)

Weill Medical College of Cornell University·interventional·Posted Nov 16, 2005·Updated Sep 25, 2018

In Brief

A Phase 4 clinical trial evaluating Lithium (LI) and Divalproex (DV) for Bipolar Disorder and Mania. Completed, enrolled 224 participants across 8 sites in 2 countries.

Detailed Summary

This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Mania
CountriesCanada, United States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2005
Enrollment StartNov 1, 2005
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.6 years ago

Interventions

Lithium (LI)drug

The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).

Divalproex (DV)drug

Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).