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

Phase 3 Completed 62 enrolled Lindner Center of HOPE Abbott · collab University of Cincinnati · collab

RandomizedSingle-groupTriple-blindTreatment

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

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

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

Summary

Timeline

Publications

Drugs

Indications