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

NCT ID: NCT00657735

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-01-31

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

Conditions

Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Deep TMS treatment

Group Type: EXPERIMENTAL

H-Coil deep TMS

Intervention Type: DEVICE

20 daily deep rTMS treatments

2

inactive stimulation

Group Type: SHAM_COMPARATOR

sham

Intervention Type: DEVICE

inactive treatment

Interventions

H-Coil deep TMS

20 daily deep rTMS treatments

Intervention Type: DEVICE

sham

inactive treatment

Intervention Type: DEVICE

Other Intervention Names

H1 coil dTMS

Eligibility Criteria

Inclusion Criteria

• 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainsway

INDUSTRY

Sponsor Role: collaborator

Shalvata Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

shalvataMHC

Hod HaSharon, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yechiel Levkovitz, MD

Role: CONTACT

ylevk@clalit.org.il

Oded Meiron, PhD student

Role: CONTACT

odedmei@clalit.org.il

Facility Contacts

Eiran v Harel, MD

Role: primary

Other Identifiers

BR-BIP-02

Identifier Type: -

Identifier Source: org_study_id