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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT01962350
Eligibility Criteria:
Inclusion Criteria: Outpatients
* Diagnosed by two senior psychiatrists as suffering from bipolar depression (BP1, BP2) episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID), with additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.
* First Stimulation threshold: intensity ≤ 70% of the threshold engine.
* Rating on HAM-D (17 items) \>18 at the screening visit.
* Age: 18-65 years.
* Gave informed consent for participation in the study.
* Negative answers on safety screening questionnaire for transcranial magnetic stimulation
* Taking mood stabilizing medication (e.g., lithium) on an acceptable range of dosage according to recent blood examination or antipsychotic medication as mood stabilizers prescribed by their treating physician
* According to the treating physician the patient is compliant in taking the mood-stabilizing medication.
* Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 2 antidepressant drug trials of adequate dose and duration in the current episode or previous episodes defined as a minimum level of 3 on the ATHF per antidepressant drug-trial.
* Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to 3 or more anti-depressant medications in the current or a previous episodes.
* If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
* Able to tolerate psychotropic medication washout and no psychotropics during the H-coil deep brain rTMS other than benzodiazepine at equivalent dose of up to 3 mg lorazepam every day.
* Right hand dominance.
Exclusion Criteria: Diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression).
* Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
* Substantial suicidal risk as judged by the treating psychiatrist.
* Attempted suicide in the past year.
* Patients with a bipolar cycle of less than 30 days.
* History of epilepsy or seizure in first degree relatives.
* History of head injury.
* History of any metal in the head (outside the mouth).
* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
* History of frequent or severe headaches.
* History of migraine.
* History of hearing loss.
* Known history of cochlear implants.
* History of substance abuse within the past 6 months (except nicotine and caffeine) or alcoholism.
* Pregnancy or not using a reliable method of birth control.
* Unstable Systemic and metabolic disorders.
* Unstable neurological or medical disease.
* Inadequate communication with the patient.
* Under custodial care.
* Participation in current clinical study or clinical study within 30 days prior to this study.
* Participants who suffer from an unstable physical disease such as high blood pressure or acute, unstable cardiac disease
* Use of fluoxetine within 6 weeks of the baseline visit
* Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the baseline visit
* Current use of antidepressant medications during the course of the trial.
* Current use of Leponex (Clozapine).
* Previous treatment with TMS
* Women who are breast-feeding
* Known or suspected pregnancy
* Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01962350
Study Brief:
Protocol Section:
NCT01962350