Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00397020
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00397020
Study Brief:
Protocol Section:
NCT00397020