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Completed

NCT Number: NCT00194116

Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression

Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must give consent to participate in the study and sign and date the IRB approved written informed consent form prior to the initiation of any study procedures
  • Subject must be between the ages of 18 and 70
  • Subject must have a diagnosis of bipolar I or II.
  • Subject must be currently depressed as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
  • Subject must have a baseline Montgomery-Asberg Depression Scale (MADRS) score of >19 and Young Mania Rating Scale (YMRS) score of <12
  • Women of childbearing potential must be nonpregnant/nonlactating and using adequate contraception if sexually active
  • Subject must not be using any concomitant psychotropic medications during the acute phase except prn benzodiazepines

Exclusion criteria

  • Subjects lacks the capacity to provide informed consent
  • Subject has currently or previously used divalproex or Dvpx-ER
  • Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
  • Subject has any alcohol, cocaine, or cannabis dependence within 3 months of study entry
  • Subject has any cocaine, hallucinogens, opiates, crystal methamphetamine, or MMDA abuse within 3 months of study entry

Treatment and study plan

divalproex sodium ER

Drug

Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

Other names: Depakote ER

Placebo

Drug

. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

Primary outcomes

  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: Acute phase (week0-week6)

    MADRS total scores range from 0-60, where higher scores are indicative of more depression.

Secondary outcomes

  1. Change in Young Mania Rating Scale (YMRS) Total Score

    Time frame: Acute phase (week0-week6)

    YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.

  2. Change in General Behavior Inventory (GBI) Depression Scale Score

    Time frame: Acute phase (week0-week6)

    GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.

  3. Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score

    Time frame: Acute phase (week0-week6)

    GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.

  4. Change in Short Form Health Survey (SF-36) Physical Component Summary Score

    Time frame: Acute phase (week0-week6)

    SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.

  5. Change in Short Form Health Survey (SF-36) Mental Component Summary Score

    Time frame: Acute phase (week0-week6)

    SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.

  6. Change in Hamilton Anxiety Rating Scale (HAMA) Total Score

    Time frame: Acute phase (week0-week6)

    HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Abbott

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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