NCT00334347

A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR

A Comparison Study of the Efficacy and Tolerability Between Depakote ER and Depakote in the Acute Treatment of Mania and Mixed Mania

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare the time to response, response rates, remission rates, and side effects in Bipolar Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.

Detailed description

There are several studies demonstrating the efficacy of divalproex in the acute treatment of mania and mixed mania. In fact, the American Psychiatric Associations Practice Guidelines for Bipolar Disorder recommends divalproex as a first-line treatment for acute mania and acute mixed mania; divalproex is the treatment of choice in the treatment of acute mixed mania. The Food and Drug Administration (FDA) approved divalproex for the acute treatment of mania in the 1990's. A new formulation, divalproex, Depakote ER, was recently FDA approved for the treatment of epilepsy and prophylaxis of migraine headaches. In a pooled data analysis of nine open-labeled trials involving 321 epilepsy and bipolar disorder patients, Smith et al. that Depakote ER was associated with superior tolerability including less frequent tremors, weight gain, and gastrointestinal complaints (all p\<0.001) compared with Depakote DR. Depakote ER was preferred by subjects and it provided improved seizure control and a greater reduction in psychiatric symptoms.

Conditions

• Mania
• Mixed Mania

Interventions

Type	Name	Description
DRUG	Depakote ER	The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
DRUG	Depakote DR	The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.

Timeline

• Start date: 2006-06-01
• Completion: 2007-09-01
• First posted: 2006-06-07
• Last updated: 2007-12-06

Locations

1 site across 1 country: United States