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

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.
 
ClinicalTrials.gov Identifier: NCT00194116
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Divalproex Sodium ER Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Study Start Date : September 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Divalproex Sodium ER Drug: Divalproex Sodium ER
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 Name: Depakote ER

Placebo Comparator: Placebo Drug: Placebo
. 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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00194116


Locations
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United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Abbott
Investigators
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Principal Investigator: Keming Gao, MD, PhD Case Western Reserve University / University Hospitals of Cleveland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Keming Gao, Director, Mood and Anxiety Clinic, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00194116    
Other Study ID Numbers: UHHS 08-03-07
First Posted: September 19, 2005    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
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