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Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
This study is not yet open for participant recruitment.
Verified by Shalvata Mental Health Center, April 2008
Sponsored by: Shalvata Mental Health Center
Information provided by: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00657735
  Purpose

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 Intervention
Bipolar Depression
Device: H-Coil deep TMS
Device: sham

MedlinePlus related topics: Antidepressants Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • change in the Hamilton depression rating scale score [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Deep TMS treatment
Device: H-Coil deep TMS
20 daily deep rTMS treatments
2: Sham Comparator
inactive stimulation
Device: sham
inactive treatment

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: 18-68 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.

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 or dependence 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.
  • Inability to locate and quantify a motor thresholds (MT) as defined in the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657735

Contacts
Contact: Yechiel Levkovitz, MD ylevk@clalit.org.il
Contact: Oded Meiron, PhD student odedmei@clalit.org.il

Sponsors and Collaborators
Shalvata Mental Health Center
  More Information

Responsible Party: Shalvata Mental Health center, Hod-Hasharon, Israel ( Dr. Yechiel Levkovitz )
Study ID Numbers: BR-BIP-02
Study First Received: April 8, 2008
Last Updated: April 11, 2008
ClinicalTrials.gov Identifier: NCT00657735  
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
bipolar
depression
prefrontal
cortex
antidepressant
response

Study placed in the following topic categories:
Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009