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A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR

Primary Purpose

Mania, Mixed Mania

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depakote ER
Depakote DR
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mania

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Depakote ER

Depakote DR

Arm Description

Outcomes

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.
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 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.
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.

Full Information

First Posted
June 5, 2006
Last Updated
December 3, 2007
Sponsor
Massachusetts General Hospital
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00334347
Brief Title
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mania, Mixed Mania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depakote ER
Arm Type
Active Comparator
Arm Title
Depakote DR
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Depakote ER
Intervention Description
The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
Intervention Type
Drug
Intervention Name(s)
Depakote DR
Intervention Description
The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
The Drug Attitude Inventory (DAI-10)will measure subjects' attitudes towards medications at the screen and final visit.
Time Frame
study duration
Title
The Schizophrenia Quality of Life Scale (SQLS)will measure subjects' quality of life at the screen and final visit.
Time Frame
study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Matthews, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR

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