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:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01864551
Eligibility Criteria:
Inclusion Criteria:
The patients aged 15 to 50 who have bipolar disorder defined by the DSM-IV in remission state(YMRS\<12, HAMD\<7, CDR\<3) for at least two months and have already received olanzapine or lamotrigine as the maintenance treatment for one month. In addition, they should have at least three hypomanic, manic, depressive or mixed episodes previously.
Exclusion Criteria:
1. The patients are not willing to participate in the study after detailed explanation.
2. The patients who could not followed the investigators' instruction
3. The patients who have severe neurological or mental illness like epileptic disorder, history of stroke, schizophrenia, schizoaffective disorder, mental retardation or uncontrolled suicide risk.
4. The patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, history of heart attack, uncontrolled hypertension.
5. The patient who are taking other mood stabilizers or antipsychotics within one month prior to the evaluation of entering our study.
6. The patients who are taking medications that might interfere with the metabolism of olanzapine or lamotrigine.
7. The patient who are allergy to olanzapine or lamotrigine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
50 Years
Study:
NCT01864551
Study Brief:
Protocol Section:
NCT01864551