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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278772
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : May 26, 2010
University of Cincinnati
Information provided by:
Lindner Center of HOPE

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania Drug: Divalproex Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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"
Study Start Date : August 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Divalproex
oral, 15mg/kg/day - 30mg/kg/day

Placebo Comparator: 2 Other: Placebo
oral dose, placebo

Primary Outcome Measures :
  1. The primary outcome measure will be change in hypomanic/manic symptoms from baseline to endpoint. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278772

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

Publications of Results:
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Responsible Party: Susan McElroy, MD / Professor, Lindner Center of HOPE Identifier: NCT00278772    
Other Study ID Numbers: 1-Miefert
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders