Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was Recruiting
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 April 17, 2014
Affective Disorders, Psychotic