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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT00699218
Eligibility Criteria:
Inclusion Criteria:
* bipolar I or II patients, currently in a depression episode
* Patient must have failed at least 2 medication
* Score of 21-item Hamilton Rating Scale for Depression (HAM-D)
Exclusion Criteria:
* Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
* Substantial risk of suicide during the screening period that requires inpatient care
* Presence of psychosis
* Dual diagnosis of other primary, currently clinically significant severe mental disorders
* History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
* History of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure
* Significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences
* Patients who are pregnant or intend to become pregnant during the study period
* Any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment
* Current Vagus Nerve Stimulation (VNS) treatment or Electroconvulsive Therapy (ECT) treatment, or with history of failed ECT treatment
* Patient's Motor Threshold for TMS cannot be detected
* Significant side effects which are intolerable during the screening or any later stage of the trial
* Started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00699218
Study Brief:
Protocol Section:
NCT00699218