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

NCT00194116 | Completed Phase 3 Results DMC

• 1 other identifier: UHHS 08-03-07
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Young Mania Rating Scale (YMRS) Total Score

  Acute phase (week0-week6)

• Change in General Behavior Inventory (GBI) Depression Scale Score

  Acute phase (week0-week6)

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

  Acute phase (week0-week6)

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

  Acute phase (week0-week6)

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

  Acute phase (week0-week6)

Study Arms (2)

Divalproex Sodium ER

EXPERIMENTAL

Drug: Divalproex Sodium ER

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Also known as: Depakote ER

Divalproex Sodium 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.

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Abbott: collaborator

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Muzina DJ, Gao K, Kemp DE, Khalife S, Ganocy SJ, Chan PK, Serrano MB, Conroy CM, Calabrese JR. Acute efficacy of divalproex sodium versus placebo in mood stabilizer-naive bipolar I or II depression: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):813-9. doi: 10.4088/JCP.09m05570gre. Epub 2010 Aug 24.

  PMID: 20816041 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Keming Gao
• Organization: Univeristy Hospitals Case Medical Center

Keming.Gao@uhhospitals.org

216-844-2865

Study Officials

• Keming Gao, MD, PhD

  Case Western Reserve University / University Hospitals of Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood and Anxiety Clinic

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: February 1, 2008
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-05

Locations

US (1)