A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Abbott
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00334347

Purpose

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.

Condition	Intervention	Phase
Mania Mixed Mania	Drug: Depakote ER Drug: Depakote DR	Phase IV

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title:	A Comparison Study of the Efficacy and Tolerability Between Depakote ER and Depakote in the Acute Treatment of Mania and Mixed Mania

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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 ]
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 ]
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 ]

Secondary Outcome Measures:

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 ]
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 ]
The Drug Attitude Inventory (DAI-10)will measure subjects' attitudes towards medications at the screen and final visit. [ Time Frame: 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 ]

Enrollment:	5
Study Start Date:	June 2006
Study Completion Date:	September 2007

Arms	Assigned Interventions
Depakote ER: Active Comparator	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.
Depakote DR: Active Comparator	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.

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.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334347

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Abbott

Investigators

Principal Investigator:

John D Matthews, M.D.

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital, Boston, Massachusetts 02114 ( John D. Matthews, MD )
Study ID Numbers:	2006-P-000671
Study First Received:	June 5, 2006
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00334347
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors

Antimanic Agents
Pharmacologic Actions
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009