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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657735
Recruitment Status : Unknown
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : April 14, 2008
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Shalvata Mental Health Center

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

Condition or disease Intervention/treatment Phase
Bipolar Depression Device: H-Coil deep TMS Device: sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2009
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Deep TMS treatment
Device: H-Coil deep TMS
20 daily deep rTMS treatments
Other Name: H1 coil dTMS

Sham Comparator: 2
inactive stimulation
Device: sham
inactive treatment

Primary Outcome Measures :
  1. change in the Hamilton depression rating scale score [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10. [ Time Frame: 7 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657735

Contact: Yechiel Levkovitz, MD
Contact: Oded Meiron, PhD student

shalvataMHC Recruiting
Hod Hasharon, Israel
Contact: Eiran v Harel, MD         
Sponsors and Collaborators
Shalvata Mental Health Center

Responsible Party: Shalvata Mental Health Center Identifier: NCT00657735     History of Changes
Other Study ID Numbers: BR-BIP-02
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Shalvata Mental Health Center:

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders