Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes

NCT00397020 | Completed Phase 4 Results

• 1 other identifier: Bipolar Mania
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine Hypothesis 3: divalproex extended-release may produce significantly less sedation

Conditions

Bipolar Disorder

Keywords

quetiapine; divalproex

Outcome Measures

Primary Outcomes (1)

• Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7

  Minimum: 0 Maximum: 60 Higher scores indicate worse outcome

  Day 7

Secondary Outcomes (7)

• Young Mania Rating Scale (YMRS) Secondary Endpoints

  weekly - Day 3, 14, 21

• Clinical Global Impression: Severity (CGI:S)

  each visit

• Clinical Global Impression: Improvement (CGI:I)

  each week/visit

• Readiness to Discharge Questionnaire (RDQ)

  each week/visit in the hospital

• Montgomery-Asberg Depression Rating Scale (MADRS)

  each week/visit

Study Arms (2)

1 Divalproex ER

EXPERIMENTAL

Divalproex ER

Drug: divalproex ER

2 Quetiapine Fumarate

ACTIVE COMPARATOR

quetiapine fumarate

Drug: quetiapine

Interventions

divalproex ER DRUG

Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml

Also known as: Depakote ER

1 Divalproex ER

quetiapine DRUG

Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.

Also known as: Seroquel

2 Quetiapine Fumarate

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent before initiation of any study-related procedures
• A diagnosis of Bipolar I Disorder, Most Recent Episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Mixed (296.5x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSMIV)
• Male or female, at least 18 years old
• YMRS score equal to or greater than 17 and a CGI of 4 (moderate) or greater.
• Female patients of childbearing potential must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation.

You may not qualify if:

• Known intolerance or lack of response to quetiapine fumarate or Divalproex ER as judged by the investigator.
• Unwilling or not able to provide informed consent
• Positive urine toxicology result on screening for cocaine, phencyclidine (PCP), opiates or amphetamines that confirms the current manic/mixed episode is better accounted by a substance intoxication or withdrawal as judged by PI.
• History of schizophrenia or schizoaffective disorder
• Treatment with a depot antipsychotic within 1 treatment cycle
• Unstable medical condition including hepatic, renal, gastroenterologic, neurologic, immunologic, or hematologic diseases that is deemed by the principle investigator to likely to result in hospitalization in 6 months or death within one year
• A female subject who is pregnant or lactating
• Lorazepam will be provided for agitation and insomnia as needed for rescue only. Not to exceed 6 mg in the first 7 days; Not to exceed 4 mg for the next 3 days and note to exceed 2 mg/day for the remainder of the study. Those that require a greater amount of Lorazepam will be excluded.
• Hospitalized for more than 1 week for current episode at the screen
• Substance or alcohol dependence at enrollment and within the three months prior to enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
• Known diagnosis of dementia or MCI

Sponsors & Collaborators

• University of California, San Diego: lead
• Abbott: collaborator

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid; Quetiapine Fumarate

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; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David Feifel
• Organization: UCSD Medical Center

dfeifel@ucsd.edu

619-543-2485

Study Officials

• David Feifel, MD, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 8, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 11, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-08

Locations

US (1)