Status:
COMPLETED
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Abbott
Conditions:
Mania
Mixed Mania
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief 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 Disor...
Eligibility Criteria
Inclusion
- Males and females between the ages 19-65 (inclusive).
- DSM-IV diagnosis of acute mania or acute mixed mania .
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00334347
Start Date
June 1 2006
End Date
September 1 2007
Last Update
December 6 2007
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114