Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomania or Mild Mania

Summary

The purpose of this research study is to evaluate the safety, tolerability, and efficacy of divalproex extended release compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex extended release is approved by the United States Food and Drug Administration (FDA) for the treatment of epilepsy and for prevention of migraine headaches.

Timeline

Start

2003-08

Primary completion

2007-12

Completion

2007-12

Outcome

Met primary endpoint

paper The divalproex ER group showed a significantly greater rate of reduction in mean total YMRS score than the placebo group (longitudinal analysis, P = .024). PMID 20361901 ↗

paper Divalproex ER begun at 15 mg/kg/d was superior to placebo in reducing hypomanic/mild manic symptoms in ambulatory BSD. PMID 20361901 ↗

Publications

• Results McElroy SL, Martens BE, Creech RS, Welge JA, Jefferson L, Guerdjikova AI, Keck PE Jr. Randomized, double-blind, placebo-controlled study of divalproex extended release loading monotherapy in ambulatory bipolar spectrum disorder patients with moderate-to-severe hypomania or mild mania. J Clin Psychiatry. 2010 May;71(5):557-65. doi: 10.4088/JCP.08m04854yel. Epub 2010 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Divalproex Sodium	Small molecule	15 mg/kg	Oral
Subject	Divalproex Sodium	Small molecule	30 mg/kg	Oral

Indications