CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 112 enrolled
Drug / intervention
Lithium +3 moredrug
Likely dose
Divalproex 45mgfrom 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/NCT01588457
NCT01588457Phase 4Completed
CompareCT.gov

Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder

The University of Texas Health Science Center at San Antonio·interventional·Posted May 1, 2012·Updated Aug 19, 2020

In Brief

A Phase 4 clinical trial evaluating Lithium, Divalproex, and 2 other interventions for Bipolar I Disorder and Bipolar II Disorder. Completed, enrolled 112 participants across 2 sites.

Detailed Summary

The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus lithium or divalproex used with lamotrigine is more effective when symptoms of depression develop.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder, Bipolar II Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2012
Enrollment StartJun 1, 2011
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.2 years ago

Interventions

Lithiumdrug

Therapeutic dosage as indicated by participants condition with blood levels. LI will be dosed to attain Li of ≥0.5mEq/L (milliequivalents per liter).

Divalproexdrug

DV will be dosed to attain DV levels of ≥45mg/L.

Lamotriginedrug

LM will be incrementally dosed up to 400 mg/day, or, in combination with DV, 200 mg/day. Dosage may be reduced for adverse effects to one half of the target dose.

Quetiapinedrug

QT will be started at 50 mg/day and titrated up to 300 mg as tolerated. QT will be discontinued if not tolerated at 100mg/day and the patient will be treated according to guidelines.