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

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00657735
• Other study ID #: BR-BIP-02
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2008
• Last updated: January 4, 2012
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2012
• Source: Shalvata Mental Health Center
• Contact: Yechiel Levkovitz, MD
• Email: ylevk[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• H-Coil deep TMS
20 daily deep rTMS treatments
• sham
inactive treatment

Locations

Country	Name	City	State
Israel	shalvataMHC	Hod Hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Brainsway

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the Hamilton depression rating scale score		7 weeks	No
Secondary	Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.		7 weeks	No