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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00334347
First received: June 5, 2006
Last updated: December 3, 2007
Last verified: December 2007
  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 4

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

Resource links provided by NLM:


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
Active Comparator: Depakote ER 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.
Active Comparator: Depakote DR 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014