A Randomized Sham-Controlled Study of H-Coil Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Late-Life Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Shalvata Mental Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01760681
First received: December 18, 2012
Last updated: January 2, 2013
Last verified: June 2012
  Purpose

The purpose of the study is to explore the efficacy and safety of H-Coil rTMS in comparison to a sham H-Coil rTMS in older patients with treatment-resistant major depressive disorder.Subjects will be randomized to receive H1-Coil rTMS or sham H1-Coil rTMS. The acute treatment phase will last four weeks. Treatment is administered daily, 5 days per week (i.e., 20 treatments). Depressive symptoms will be assessed using the HDRS-24. If subjects achieve the pre-defined primary outcome criteria of remission (HDRS-24 score < 10 and 60% reduction in symptoms) they will continue with twice weekly treatment for two more weeks to ensure the durability of the remission. Subjects who do not achieve remission will exit the study after the acute treatment phase of four weeks. The blind will not be broken to subjects until the completion of the study


Condition Intervention
Depression
Device: H- Coil DTMS
Device: Sham

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

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Improvement in depression symptoms, evaluated by HDRS [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    Clinical antidepressant response at the end of the treatment, define as a decline in Hamilton depression rating scale (HDRS-24) from the baseline rating by 50%.


Secondary Outcome Measures:
  • 1. Remission in depression [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    1. Clinical antidepressant remission at the end of the treatment, define as exit HDRS-24 <10 and 60% reduction in total score.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H coil DTMS
20 daily deep TMS treatments
Device: H- Coil DTMS
20 daily deep rTMS treatments
Other Name: H1 coil DTMS
Sham Comparator: inactive stimulation
20 daily sham deep TMS treatments
Device: Sham
Other Name: inactive treatment

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are outpatients
  2. are voluntary and competent to consent to treatment
  3. have a Structured Clinical Interview for DSM-IV (SCID)103 confirmedn DSM-IV diagnosis of MDD, single or recurrent
  4. are between the ages of 60 and 85
  5. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode 104, 105 OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
  6. have a score > 22 on the HDRS-24
  7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  8. able to adhere to the treatment schedule
  9. Pass the TMS safety screening questionnaire
  10. have normal thyroid functioning based on pre-study blood work.

Exclusion Criteria:

  1. have a history of DSM-IV substance dependence or abuse within the last 3 months
  2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  3. are acutely suicidal
  4. are pregnant
  5. have a lifetime SCID diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
  6. have a SCID diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder) assessed by a study investigator to be primary and causing greater impairment than MDD
  7. have a SCID diagnosis of any personality disorder and assessed by a study investigator to be primary and causing greater impairment than MDD
  8. have presumed or probable dementia, as defined by Mini Mental Status Exam (MMSE) < 26 and clinical evidence of dementia. Patients screened out due to possible dementia will be referred to the local memory clinic for evaluation to clarify the presence or absence of dementia
  9. have failed a course of ECT within the current depressive episode
  10. have received rTMS for any previous indication due to the potential compromise of subject blinding
  11. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
  12. on a dose of Buproprion greater than 300mg per day
  13. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
  14. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
  15. clinically significant laboratory abnormality, in the opinion of the investigator
  16. currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
  17. inability to communicate
  18. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760681

Contacts
Contact: Yechiel Levkovich, M.D ylevk@clalit.org.il

Locations
Israel
shalvataMHC Not yet recruiting
Hod Hasharon, Israel
Contact: Yechiel Levkovich, Prof.    972-9-7478569      
Sponsors and Collaborators
Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01760681     History of Changes
Other Study ID Numbers: SHA-14-12
Study First Received: December 18, 2012
Last Updated: January 2, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014