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

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ClinicalTrials.gov Identifier: NCT00397020
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
David Feifel, University of California, San Diego

Study Description
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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


Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: divalproex ER Drug: quetiapine Phase 4

Detailed Description:
This will be a rater-blinded, head-to-head comparison (no placebo) of divalproex ER and quetiapine in patients with symptoms of an active manic or mixed mania (symptoms of mania and depression). Forty subjects are expected to be enrolled. After screening for eligibility, eligible subjects will be randomized while hospitalized in a 1:1 ratio into 2 treatment groups: divalproex ER or quetiapine. Depakote® ER will be given orally at 30 mg/kg day initially taken at night and rounded up to nearest 500 mg dose with adjustments made through the trial as needed to obtain serum valproic acid levels of 85-125 mcg/ml. Quetiapine will be given orally at an initial dose of 200mg/day on Day 1, and titrate up to 800 mg/day. The duration of the study will be 21 days from baseline and the total number of visits including screening is five. Patients will be released from the hospital once stable and visits for the study will then take place on an outpatient basis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-Blind, Randomized, Naturalistic Pilot Study, Comparison of Divalproex ER and Quetiapine for Adults With Acute Mania or Mixed Episodes
Study Start Date : December 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Divalproex ER
Divalproex ER
 Drug: divalproex ER
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
Other Name: Depakote ER
Active Comparator: 2 Quetiapine Fumarate
quetiapine fumarate
 Drug: quetiapine
Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.
Other Name: Seroquel


Outcome Measures
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Primary Outcome Measures :
  1. Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7 [ Time Frame: Day 7 ]
    Minimum: 0 Maximum: 60 Higher scores indicate worse outcome


Secondary Outcome Measures :
  1. Young Mania Rating Scale (YMRS) Secondary Endpoints [ Time Frame: weekly - Day 3, 14, 21 ]
  2. Clinical Global Impression: Severity (CGI:S) [ Time Frame: each visit ]
  3. Clinical Global Impression: Improvement (CGI:I) [ Time Frame: each week/visit ]
  4. Readiness to Discharge Questionnaire (RDQ) [ Time Frame: each week/visit in the hospital ]
  5. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: each week/visit ]
  6. Behavioral Activity Rating Scale (BARS) [ Time Frame: each week/visit ]
  7. Extrapyramidal Symptoms Rating Scale (ESRS) [ Time Frame: each week/visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For inclusion, patients must fulfill all of the following criteria at enrollment:

  1. Provide written informed consent before initiation of any study-related procedures
  2. 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)
  3. Male or female, at least 18 years old
  4. YMRS score equal to or greater than 17 and a CGI of 4 (moderate) or greater.
  5. 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.

Exclusion Criteria:

  1. Known intolerance or lack of response to quetiapine fumarate or Divalproex ER as judged by the investigator.
  2. Unwilling or not able to provide informed consent
  3. 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.
  4. History of schizophrenia or schizoaffective disorder
  5. Treatment with a depot antipsychotic within 1 treatment cycle
  6. 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
  7. A female subject who is pregnant or lactating
  8. 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.
  9. Hospitalized for more than 1 week for current episode at the screen
  10. 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.
  11. Known diagnosis of dementia or MCI
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397020


Locations
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United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Abbott
Investigators
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Principal Investigator: David Feifel, MD, PhD UCSD
More Information
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Responsible Party: David Feifel, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00397020    
Other Study ID Numbers: Bipolar Mania
First Posted: November 8, 2006    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: August 2019
Keywords provided by David Feifel, University of California, San Diego:
quetiapine
divalproex
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents