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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194116
• Other study ID #: UHHS 08-03-07
• Status: Completed
• Phase: Phase 3
• Start date: September 2004
• Est. completion date: February 2008

Study information

• Verified date: May 2019
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	MADRS total scores range from 0-60, where higher scores are indicative of more depression.	Acute phase (week0-week6)
Secondary	Change in Young Mania Rating Scale (YMRS) Total Score	YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.	Acute phase (week0-week6)
Secondary	Change in General Behavior Inventory (GBI) Depression Scale Score	GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.	Acute phase (week0-week6)
Secondary	Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score	GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.	Acute phase (week0-week6)
Secondary	Change in Short Form Health Survey (SF-36) Physical Component Summary Score	SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.	Acute phase (week0-week6)
Secondary	Change in Short Form Health Survey (SF-36) Mental Component Summary Score	SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.	Acute phase (week0-week6)
Secondary	Change in Hamilton Anxiety Rating Scale (HAMA) Total Score	HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.	Acute phase (week0-week6)