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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT01737268
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of bipolar I or II disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR), with a major depressive episode
* Able to participate in the study with understanding of and compliance with subject requirements during the study in the investigator's or subinvestigator's opinion
* Male subjects must agree to take appropriate contraceptive measures with condoms during the study period.
* Female subjects must be confirmed to have no childbearing potential during the study period
Exclusion Criteria:
* Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolar disorder, within the last 6 months before informed consent
* Concurrence of DSM-IV-TR Axis II disorder that was considered to greatly affect patient's current mental status.
* The Young Mania Rating Scale (YMRS) total score of 13 points or more.
* Nine or more mood episodes within the last 12 months before informed consent.
* Lack of response to at least 6-week treatment with at least 2 antidepressants for the current major depressive episode in the investigator's or subinvestigator's opinion
* The current major depressive episode persisting for more than 12 months or less than 4 weeks before informed consent.
* History of substance dependence (other than caffeine and nicotine) or alcohol abuse or dependence.
* Treatment with a depot antipsychotic within the last 49 days before primary registration.
* Unable to suspend antipsychotics or antidepressants after primary registration
* Treatment with two or more of mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drug, cannot be suspended after primary registration.
* Unable to suspend antiepileptics (except lamotrigine and sodium valproate), antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents, cerebral ameliorators, antidementia agents, or anorectics, except those specified as conditionally-allowed concomitant drugs, from 7 days before primary registration
* Electroconvulsive therapy within the last 83 days before primary registration.
* A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before primary registration).
* The Hamilton Depression Rating Scale (HAM-D17) suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01737268
Study Brief:
Protocol Section:
NCT01737268