- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397020
Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes
A Single-Blind, Randomized, Naturalistic Pilot Study, Comparison of Divalproex ER and Quetiapine for Adults With Acute Mania or Mixed Episodes
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- Ucsd Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For inclusion, patients must fulfill all of the following criteria at enrollment:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Divalproex ER
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 Names:
|
Active Comparator: 2 Quetiapine Fumarate
quetiapine fumarate
|
Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7
Time Frame: Day 7
|
Minimum: 0 Maximum: 60 Higher scores indicate worse outcome
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Young Mania Rating Scale (YMRS) Secondary Endpoints
Time Frame: weekly - Day 3, 14, 21
|
weekly - Day 3, 14, 21
|
Clinical Global Impression: Severity (CGI:S)
Time Frame: each visit
|
each visit
|
Clinical Global Impression: Improvement (CGI:I)
Time Frame: each week/visit
|
each week/visit
|
Readiness to Discharge Questionnaire (RDQ)
Time Frame: each week/visit in the hospital
|
each week/visit in the hospital
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: each week/visit
|
each week/visit
|
Behavioral Activity Rating Scale (BARS)
Time Frame: each week/visit
|
each week/visit
|
Extrapyramidal Symptoms Rating Scale (ESRS)
Time Frame: each week/visit
|
each week/visit
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Feifel, MD, PhD, UCSD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
- Quetiapine Fumarate
Other Study ID Numbers
- Bipolar Mania
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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