Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression

Shalvata Mental Health Center

Status

Unknown

Conditions

Bipolar Depression

Treatments

Device: H-Coil deep TMS

Device: sham

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00657735

BR-BIP-02

Details and patient eligibility

About

The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications

Enrollment

50 estimated patients

Sex

All

Ages

18 to 68 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.
Rating on HAM-D (17 items) >20 and item 1 ≥2 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.