Borderline Personality Disorder Clinical Trial
This is an open study.approximately 20 patients diagnosed with Borderline Personality
Disorder (in case patient is under drug treatment, treatment should be stable within the
prior 4 weeks before study entry).Starting from the third day, subjects would undergo rTMS
(repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks, and
will be clinically evaluated in order to monitor for improvement.
The investigators anticipate a significant reduction in symptoms severity at the end of the
treatment compared to study entry.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Men and woman between the ages of 18-60 - Diagnosed as suffering from Borderline Personality Disorder according to the DSM IV, as determined by a senior psychiatrist on the basis of the Structured Clinical Interview for DSM-IV Axis I - pharmocological treatment stays constant for the duration of the study - Gave informed consent for participation in the study - Not pregnant Exclusion Criteria: - Electroconvulsive therapy (ECT) less than 9 months prior to screening. - suicide risk (assessed by the patient's doctor) - Suffer from active AXIS I disorder (according to the DSM IV)during the 3 months before study entry(besides: eating disorder, phobia and somatoform disorder) - History of seizure or heat convulsion. - 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. - Pregnancy or not using a reliable method of birth control. - Inadequate communication with the patient. - Under custodial care. - Participation in current clinical study or - A significant physical illness which is not balanced. - Cerebral Palsy, history of encephalitis or other structural brain damage. - Pseudotumor cerebri - neurological deficit - Patients using high dosage of antipsychotic medicine : more than 7.5 mg Haldol, 10 mg Olanzapine, 4 mg Risperdal, 400 mg SEROQUEL, 120 mg Geodon, 100 mg Clopixol, 12 mg Perphenan. Patients taking Clozapine will not be recruited to the present study In case of taking other antipsychotic medicine besides those listed above, the principal investigator will decide whether patients are eligible for recruitment . |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Shalvata Mental Health Center | Hod Hasharon, |
Lead Sponsor | Collaborator |
---|---|
Shalvata Mental Health Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in ZAN-BPD | every 2 weeks, up to 4 weeks. | No |
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