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

Not Applicable

• Conditions: Bipolar Depression
• Interventions: Device: sham; Device: H-Coil deep TMS

• Registration Number: NCT00657735
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Study Start: 2009-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-05
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	sham	inactive stimulation
1	H-Coil deep TMS	Deep TMS treatment

Primary Outcome Measures

Name	Time	Method
change in the Hamilton depression rating scale score	7 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.	7 weeks

Trial Locations

Locations (1)

shalvataMHC; 🇮🇱 Hod Hasharon, Israel