A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR

NCT00334347 | Completed Phase 4

• 1 other identifier: 2006-P-000671
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the time to response, response rates, remission rates, and side effects in Bipolar Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.

Conditions

Mania; Mixed Mania

Outcome Measures

Primary Outcomes (3)

• The Young Mania Rating Scale (YMRS)will be used daily for the first week and then every three day to assess the severity of mania.

  study duration

• The Clinical Global Impression Scale (CGI) will be used daily for teh first week then every 3 days to assess overall functioning.

  study duration

• The Udvalg for Kliniske Undersogeiser (UKU) Side Effect Rating Scale will be administered at base line and weekly for the remainder of the study to determine the medication side effect profiles.

  study duration

Secondary Outcomes (4)

• The Montgomery-Asberg Depression Rating Scale will be performed daily for the first week and weekly thereafter to assess for any emergent symptoms of depression.

  study duration

• The Brief Psychiatric Rating Scale (BPRS) will be performed daily for the first week and weekly thereafter to assess for any emergent symptoms of psychosis.

  study duration

• The Drug Attitude Inventory (DAI-10)will measure subjects' attitudes towards medications at the screen and final visit.

  study duration

• The Schizophrenia Quality of Life Scale (SQLS)will measure subjects' quality of life at the screen and final visit.

  study duration

Study Arms (2)

Depakote ER

ACTIVE COMPARATOR

Drug: Depakote ER

Depakote DR

ACTIVE COMPARATOR

Drug: Depakote DR

Interventions

Depakote ER DRUG

The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.

Depakote ER

Depakote DR DRUG

The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.

Depakote DR

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between the ages 19-65 (inclusive).
• DSM-IV diagnosis of acute mania or acute mixed mania .

You may not qualify if:

• DSM-IV diagnoses of bipolar disorder, depressed type, bipolar disorder rapid cycling type, major depressive disorder with psychotic features, schizoaffective disorder, schizophrenia, substance use disorder (active use within the last 3 months), or organic mood disorder.
• History of a seizure disorder or an unstable physical disorder judged to significantly affect central nervous system function.
• Female subjects who are pregnant or of childbearing potential who are not using medically accepted means of contraception and female patients who are breastfeeding.
• Subjects who require antipsychotic medications because of severe psychosis and /or agitation.
• Subjects on antidepressants or mood stabilizers including lithium, oxcarbazepine, carbamazepine, and lamotrigine.
• Subjects who have failed previous trials with Depakote DR or Depakote ER.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Abbott: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Mania

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• John D Matthews, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2006
• First Posted: June 7, 2006
• Study Start: June 1, 2006
• Study Completion: September 1, 2007
• Last Updated: December 6, 2007

Record last verified: 2007-12

Locations

US (1)