MedDataX Logo

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

NCT ID: NCT00334347

Last Updated: 2007-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mania Mixed Mania

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Depakote ER

Group Type ACTIVE_COMPARATOR

Depakote ER

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Depakote DR

Intervention Type DRUG

The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Massachusetts General Hospital, Boston, Massachusetts 02114

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John D Matthews, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-P-000671

Identifier Type: -

Identifier Source: org_study_id