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

NCT00657735 | Unknown DMC

• 1 other identifier: BR-BIP-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

bipolar; depression; prefrontal; cortex; antidepressant; response

Outcome Measures

Primary Outcomes (1)

• change in the Hamilton depression rating scale score

  7 weeks

Secondary Outcomes (1)

• Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.

  7 weeks

Study Arms (2)

1

EXPERIMENTAL

Deep TMS treatment

Device: H-Coil deep TMS

2

SHAM COMPARATOR

inactive stimulation

Device: sham

Interventions

H-Coil deep TMS DEVICE

20 daily deep rTMS treatments

Also known as: H1 coil dTMS

1

sham DEVICE

inactive treatment

2

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• Brainsway: collaborator

Study Sites (1)

shalvataMHC

Hod HaSharon, Israel

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Yechiel Levkovitz, MD

CONTACT

ylevk@clalit.org.il

Oded Meiron, PhD student

CONTACT

odedmei@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

IL (1)