- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00334347
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
December 3, 2007 updated by: Massachusetts General Hospital
A Comparison Study of the Efficacy and Tolerability Between Depakote ER and Depakote in the Acute Treatment of Mania and Mixed Mania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Young Mania Rating Scale (YMRS)will be used daily for the first week and then every three day to assess the severity of mania.
Time Frame: study duration
|
study duration
|
The Clinical Global Impression Scale (CGI) will be used daily for teh first week then every 3 days to assess overall functioning.
Time Frame: study duration
|
study duration
|
The Udvalg for Kliniske Undersogeiser (UKU) Side Effect Rating Scale will be administered at base line and weekly for the remainder of the study to determine the medication side effect profiles.
Time Frame: study duration
|
study duration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Montgomery-Asberg Depression Rating Scale will be performed daily for the first week and weekly thereafter to assess for any emergent symptoms of depression.
Time Frame: study duration
|
study duration
|
The Brief Psychiatric Rating Scale (BPRS) will be performed daily for the first week and weekly thereafter to assess for any emergent symptoms of psychosis.
Time Frame: study duration
|
study duration
|
The Drug Attitude Inventory (DAI-10)will measure subjects' attitudes towards medications at the screen and final visit.
Time Frame: study duration
|
study duration
|
The Schizophrenia Quality of Life Scale (SQLS)will measure subjects' quality of life at the screen and final visit.
Time Frame: study duration
|
study duration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John D Matthews, M.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
June 5, 2006
First Submitted That Met QC Criteria
June 5, 2006
First Posted (Estimate)
June 7, 2006
Study Record Updates
Last Update Posted (Estimate)
December 6, 2007
Last Update Submitted That Met QC Criteria
December 3, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Mania
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
Other Study ID Numbers
- 2006-P-000671
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mania
-
Cedars-Sinai Medical CenterNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar Disorder | Mixed Mania | Treatment-Resistant ManiaUnited States
-
University of Texas Southwestern Medical CenterRecruitingMania (Neurotic)United States
-
Taichung Veterans General HospitalUnknownBipolar, Mania | Utapine | SeroquelTaiwan
-
AstraZenecaTerminated
-
Mclean HospitalWithdrawnBipolar, Mania | Bipolar, Mixed State
-
AstraZenecaTerminated
-
Assiut UniversityCompleted
-
Otsuka Pharmaceutical Development & Commercialization...Otsuka America PharmaceuticalCompletedBipolar Disorder ManiaItaly, Poland, Russian Federation, Turkey, South Africa, Austria, Hungary, France, Spain, Czech Republic, Germany, Greece, Romania
-
Otsuka Pharmaceutical Development & Commercialization...H. Lundbeck A/SCompletedBipolar I Disorder | Acute ManiaUnited States, Serbia, Bulgaria, Croatia, Poland, Ukraine
-
Lindner Center of HOPEUniversity of Cincinnati; AbbottCompletedBipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild ManiaUnited States
Clinical Trials on Depakote ER
-
AbbottCompletedPediatric EpilepsyUnited States
-
University Hospitals Cleveland Medical CenterAbbottCompleted
-
Medical University of South CarolinaWithdrawnGlioma | Glioblastoma | Medulloblastoma | Anaplastic Astrocytoma | Pediatric Brain TumorUnited States
-
University Hospitals Cleveland Medical CenterAbbottCompletedBipolar DisorderUnited States
-
University of CincinnatiAbbottWithdrawnBehavioral Symptoms | Dementia | Alzheimer's DiseaseUnited States
-
University of California, San DiegoAbbottCompleted
-
Cambridge Health AllianceNorthwestern UniversityCompletedBipolar Disorder
-
Palo Alto Veterans Institute for ResearchNational Institute of Mental Health (NIMH)Completed
-
State University of New York - Upstate Medical...CompletedBladder Cancer | HematuriaUnited States
-
Stanford UniversityNational Alliance for Research on Schizophrenia and Depression; AbbottCompleted