A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
Information source: Massachusetts General Hospital
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Condition(s) targeted: Mania; Mixed Mania
Intervention: Depakote ER (Drug); Depakote DR (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): John D Matthews, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: A Comparison Study of the Efficacy and Tolerability Between Depakote ER and Depakote in the Acute Treatment of Mania and Mixed Mania
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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.The Clinical Global Impression Scale (CGI) will be used daily for teh first week then every 3 days to assess overall functioning. 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.
Secondary outcome: 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.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. The Drug Attitude Inventory (DAI-10)will measure subjects' attitudes towards medications at the screen and final visit. The Schizophrenia Quality of Life Scale (SQLS)will measure subjects' quality of life at the screen and final visit.
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
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: June 2006
Last updated: December 3, 2007
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