Clinical trial NCT00657735: Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
Official title: A Prospective Double Blind Randomized Controlled Trial To Explore The Tolerability, Safety And Efficacy Of The H1-Coil Deep Transcranial Magnetic Stimulation (TMS) In Subjects With Bipolar Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Depression
Keywords: bipolar
depression
prefrontal
cortex
antidepressant
response
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Brainsway
First posted: 2008-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


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.
* 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.

Primary outcomes:
measure: change in the Hamilton depression rating scale score
timeFrame: 7 weeks
Secondary outcomes:
measure: Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: shalvataMHC
Study officials:
References: