Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
This study is currently recruiting participants.
Verified January 2012 by Shalvata Mental Health Center
Information provided by (Responsible Party):
Shalvata Mental Health Center
First received: April 8, 2008
Last updated: January 4, 2012
Last verified: January 2012
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
Device: H-Coil deep TMS
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
Deep TMS treatment
Device: H-Coil deep TMS
20 daily deep rTMS treatments
Other Name: H1 coil dTMS
Sham Comparator: 2
|Ages Eligible for Study:
||18 Years to 68 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657735
|Hod Hasharon, Israel |
|Contact: Eiran v Harel, MD |
Shalvata Mental Health Center
No publications provided
||Shalvata Mental Health Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 8, 2008
||January 4, 2012
||Israel: Ministry of Health
Keywords provided by Shalvata Mental Health Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Affective Disorders, Psychotic