Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER

NCT00211250 | Completed Phase 4 DMC

• 1 other identifier: JCCR-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare compliance, tolerability, effectiveness, and side-effects in Bipolar I and II patients switching from Valproic Acid to Depakote ER.

Conditions

Mood Disorder

Keywords

Depakote Er and Valproic Acid

Outcome Measures

Primary Outcomes (2)

• Primary Measure: Safety and Tolerability.

• Comparisons will be made between baseline and final measures of adverse events and UKU results.

Secondary Outcomes (2)

• Secondary Measures: Compliance and efficacy.

• Comparison of YMRS and MADRS scores

Interventions

Valproic Acid and Depakote ER DRUG

Eligibility Criteria

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

You may qualify if:

• Bipolar I and II patients, age 18 and older, currently tolerating a stable dose of Valproic Acid for at least 3 months with a current Valproic Acid level of at least 50 mcg/mL at screening and baseline,

You may not qualify if:

• Women who are pregnant or breast feeding or intending to become pregnant, contraindication or history of hypersensitivity to valproic acid, DVPX or DVPX ER.
• Clinically significant organ disease, clinically significant abnormalities in physical examination, EKG, or lab test, history of any disease which in the investigator's opinion may confound the results of the study or pose additional risk.
• Other principle nonpsychotic or psychotic psychiatric diagnosis. Patients weighing \>300 pounds.
• Patients taking any other mood stabilizers.
• Patients not already on a stable dose of valproic acid or have a Valproic Acid level less than 50 mcg/mL at screening.

Sponsors & Collaborators

• Joliet Center for Clinical Research: lead
• Abbott: collaborator

Study Sites (1)

Cosme Lozano M.D.

Joliet, Illinois, 60435, United States

Location

Related Publications (1)

• Berk, M & Berk, L. (2004). Mood stabilizers and treatment adherence in bipolar disorder: addressing adverse events. Bowden C.L., Calabrese J.R., McElroy S.L., Gyulai L., Wassef A., Petty F., Pope H.G. Jr, Chou J.C., Keck P.E. Jr, Rhodes L.J., Swann A.C., Hirschfeld R.M., Wozniak P.J., (2000). Valproate in the treatment of acute mania: placebo-controlled study. Archives of General Psychiatry, 48, 62-68. Pope, S. J. (2002). Nonadherence with mood stabilizers: prevalence and predictors. Journal of Clinical Psychiatry, 63, 384-90. Sajatovic, M., Davies M., & Hrouda, D.R. (2004). Enhancement of treatment adherence with patients with bipolar disorder. Psychiatric Services, 55(3), 264-69. Depakote ER package insert, Abbott Laboratories, 2002.

  BACKGROUND

Related Links

• Research Site

MeSH Terms

Conditions

Mood Disorders

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Cosme O Lozano, M.D.

  JCCR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2006
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

US (1)