Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomania or Mild Mania

This study has been completed.
Sponsor:
Collaborators:
Abbott
University of Cincinnati
Information provided by:
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00278772
First received: January 13, 2006
Last updated: May 24, 2010
Last verified: May 2010
  Purpose

The purpose of this research study is to evaluate the safety, tolerability, and efficacy of divalproex extended release compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex extended release is approved by the United States Food and Drug Administration (FDA) for the treatment of epilepsy and for prevention of migraine headaches.


Condition Intervention Phase
Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania
Drug: Divalproex
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: "A Randomized, Double-Blind, Placebo-Controlled Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania"

Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • The primary outcome measure will be change in hypomanic/manic symptoms from baseline to endpoint. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: August 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Divalproex
Drug: Divalproex
oral, 15mg/kg/day - 30mg/kg/day
Placebo Comparator: 2 Other: Placebo
oral dose, placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be 18 years of age or older.
  2. Subjects must have bipolar I, II, or NOS disorder as defined by DSM-IV-TR. (Bipolar NOS will include hypomania defined as in DSM-IV-TR, as well as "brief" hypomania-hypomania occurring for a duration of > 1 day but < 4 days - and antidepressant associated hypomania and mania).
  3. Subjects must have moderate-to-severe hypomania or mild mania within the past 2 weeks, defined as having a YMRS >10 and < 21 at the baseline assessment.
  4. Subjects' overall bipolar symptoms must be clinically significant but not greater than severe (defined as a CGI-BP >2 and < 5).
  5. Subjects must be outpatients.
  6. Subjects must be on no psychotropics for 1 week (2 weeks for fluoxetine and 4 weeks for depot antipsychotics) except for prn lorazepam (.5-2mg/day) or zaleplon (5-10mg qhs).
  7. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
  8. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, intrauterine device) for at least one month prior to study entry and throughout the study.

Exclusion Criteria:

  1. Subjects who do not have bipolar disorder by above DSM-IV-TR criteria.
  2. Subjects whose bipolar symptoms are more than severely ill (CGI-BP > 5, YMRS > 21, or IDS > 39).
  3. Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
  4. Subjects who require hospitalization.
  5. Subjects with clinically significant suicidal ideation, homicidal ideation, or psychotic features.
  6. Subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders or a lifetime psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
  7. Subjects with DSM-IV Axis I substance dependence within the past 3 months (except for nicotine dependence).
  8. Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.
  9. Subjects who are allergic to or who have demonstrated hypersensitivity to any valproate or divalproex preparation.
  10. Women who are pregnant or nursing.
  11. Subjects who have received an experimental drug or used an experimental device within 30 days.
  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: NCT00278772

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Lindner Center of HOPE
Abbott
University of Cincinnati
Investigators
Principal Investigator: Susan L. McElroy, MD University of Cincinnati
  More Information

Publications:
Responsible Party: Susan McElroy, MD / Professor, Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00278772     History of Changes
Other Study ID Numbers: 1-Miefert
Study First Received: January 13, 2006
Last Updated: May 24, 2010
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 19, 2014