Sequential Multiple Assignment Treatment for Bipolar Disorder

PHASE4CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Bipolar I DisorderBipolar II Disorder
Interventions
DRUG

Lithium

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

DRUG

Divalproex

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

DRUG

Lamotrigine

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.

DRUG

Quetiapine

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.

Trial Locations (2)

44106

Case Western Reserve University, Cleveland

78229-3900

University of Texas Health Science Center, San Antonio

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT01588457 - Sequential Multiple Assignment Treatment for Bipolar Disorder | Biotech Hunter | Biotech Hunter