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

Completed · Phase 4

Conditions studied: Mania, Mixed Mania

In brief

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.

Key facts

Study ID

NCT00334347

Run by

Massachusetts General Hospital

People needed

5

Starts

2006-06-01

Expected to finish

2007-09-01

Last updated by the study team

2007-12-06

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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