Skip to main content

Advertisement

Table 1 Inclusion Criteria

From: The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation

Inclusion Criteria
1. Subjects aged 7 years to 17 years, 11 months old at time of first dose
2. Patients must meet DSM-IV diagnostic criteria, as assessed by a semi -structured assessment (KSADS-PL) and a separate clinical interview with a child/adolescent psychiatrist for manic or mixed episodes in bipolar I disorder
3. Score of > 20 on the YMRS at screening and baseline
4. The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
5. Patients with comorbid conditions [attention deficit hyperactivity disorder (ADHD), conduct disorder] may participate.
6. If female: is premenarchal, or is incapable of pregnancy because of a hysterectomy, tubal ligation, or spousal/partner sterility. If sexually active and capable of pregnancy, has been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least one month prior to study entry and agrees to continue to use one of these for the duration of the study. If sexually abstinent and capable of pregnancy, agrees to continued abstinence or to use of an acceptable method of birth control (either intrauterine device or spermicide and barrier) should sexual activity commence
7. Has a negative quantitative serum ß-human chorionic gonadotrophin hormone pregnancy test at screening and a negative qualitative urine pregnancy test at baseline, if female
8. Patients with a history of substance abuse may participate if they agree to abstain from drugs during the trial and have a negative drug screen at screening or prior to baseline.
9. The subject is willing and clinically able to wash out of exclusionary medication during the screening period. Prior to the administration of lithium, patients will not have used any of the following mediations: antipsychotics, monoamine oxidase inhibitors, antidepressants within the preceding two weeks; stimulants within the preceding week; or fluoxetine or depot antipsychotics in the past month (no stable patients will be asked to discontinue medications)
10. ECG and blood work including CBC, prothrombin/partial thromboplastin time, fibrinogen, and thyroid function showing no clinically significant abnormalities