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

NCT00278772 | Completed Phase 3

• 1 other identifier: 1-Miefert
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be change in hypomanic/manic symptoms from baseline to endpoint.

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

Divalproex

Drug: Divalproex

2

PLACEBO COMPARATOR

Other: Placebo

Interventions

Divalproex DRUG

oral, 15mg/kg/day - 30mg/kg/day

1

Placebo OTHER

oral dose, placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18 years of age or older.
• 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).
• 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.
• Subjects' overall bipolar symptoms must be clinically significant but not greater than severe (defined as a CGI-BP \>2 and \< 5).
• Subjects must be outpatients.
• 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).
• Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
• 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.

You may not qualify if:

• Subjects who do not have bipolar disorder by above DSM-IV-TR criteria.
• Subjects whose bipolar symptoms are more than severely ill (CGI-BP \> 5, YMRS \> 21, or IDS \> 39).
• 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.
• Subjects who require hospitalization.
• Subjects with clinically significant suicidal ideation, homicidal ideation, or psychotic features.
• 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).
• Subjects with DSM-IV Axis I substance dependence within the past 3 months (except for nicotine dependence).
• 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.
• Subjects who are allergic to or who have demonstrated hypersensitivity to any valproate or divalproex preparation.
• Women who are pregnant or nursing.
• Subjects who have received an experimental drug or used an experimental device within 30 days.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Abbott: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related Publications (1)

• McElroy SL, Martens BE, Creech RS, Welge JA, Jefferson L, Guerdjikova AI, Keck PE Jr. Randomized, double-blind, placebo-controlled study of divalproex extended release loading monotherapy in ambulatory bipolar spectrum disorder patients with moderate-to-severe hypomania or mild mania. J Clin Psychiatry. 2010 May;71(5):557-65. doi: 10.4088/JCP.08m04854yel. Epub 2010 Feb 23.

  PMID: 20361901 RESULT

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Susan L. McElroy, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2006
• First Posted: January 18, 2006
• Study Start: August 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 26, 2010

Record last verified: 2010-05

Locations

US (1)