A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
NCT00334347 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2007-12-06
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.
Conditions
- Mania
- Mixed Mania
Interventions
- 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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
John D Matthews, M.D. · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-06-30
- Completion
- 2007-09-30
Countries
- United States
Study Locations
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