DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder

PHASE4TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

October 24, 2016

Primary Completion Date

November 1, 2018

Study Completion Date

November 1, 2018

Conditions
Bipolar Disorder
Interventions
DRUG

Carbamazepine

200-1200 mg by mouth daily given in divided doses in the morning and the evening. Doses are titrated weekly in 200 mg increments based upon subject's response.

DRUG

Placebo

Dosage to match active treatment by mouth twice daily in the morning and in the evening.

Trial Locations (4)

21205

Kennedy Krieger Institute, Baltimore

32803

APG Research, LLC, Orlando

63128

PsychCare Consultants, St Louis

77090

Red Oak Psychiatry Associates, PA, Houston

Sponsors
All Listed Sponsors
lead

Validus Pharmaceuticals

INDUSTRY