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

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Mixed Mania

Mania

Treatments

Drug: Depakote DR

Drug: Depakote ER

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00334347

2006-P-000671

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females between the ages 19-65 (inclusive).
DSM-IV diagnosis of acute mania or acute mixed mania .

Exclusion criteria

DSM-IV diagnoses of bipolar disorder, depressed type, bipolar disorder rapid cycling type, major depressive disorder with psychotic features, schizoaffective disorder, schizophrenia, substance use disorder (active use within the last 3 months), or organic mood disorder.
History of a seizure disorder or an unstable physical disorder judged to significantly affect central nervous system function.
Female subjects who are pregnant or of childbearing potential who are not using medically accepted means of contraception and female patients who are breastfeeding.
Subjects who require antipsychotic medications because of severe psychosis and /or agitation.
Subjects on antidepressants or mood stabilizers including lithium, oxcarbazepine, carbamazepine, and lamotrigine.
Subjects who have failed previous trials with Depakote DR or Depakote ER.