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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Abbott
• Treatments: Valproic Acid

Criteria

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.