Phase 4
Completed N=30
Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes
Source: ClinicalTrials.gov NCT00397020 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7 — 14.8; 13.9 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7 |
14.8; 13.9 | — |
| SECONDARY Young Mania Rating Scale (YMRS) Secondary Endpoints |
— | — |
| SECONDARY Clinical Global Impression: Severity (CGI:S) |
— | — |
| SECONDARY Clinical Global Impression: Improvement (CGI:I) |
— | — |
| SECONDARY Readiness to Discharge Questionnaire (RDQ) |
— | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) |
— | — |
| SECONDARY Behavioral Activity Rating Scale (BARS) |
— | — |
| SECONDARY Extrapyramidal Symptoms Rating Scale (ESRS) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00397020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.