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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT00035802
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version \[K-SADS-P/L\])
* YMRS score greater than or equal to 20
* General good health as determined by medical history, physical examination, and laboratory evaluations
* Ability to swallow tablets
* Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment
* Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients
Exclusion Criteria:
* DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS)
* DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator
* Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis
* Weight less than 33 kg or current or past history of anorexia nervosa
* Serious or unstable medical or neurological conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT00035802
Study Brief:
Protocol Section:
NCT00035802