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

NCT ID: NCT01760681

Last Updated: 2013-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31

Brief Summary

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

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

H coil DTMS

20 daily deep TMS treatments

Group Type: EXPERIMENTAL

H- Coil DTMS

Intervention Type: DEVICE

20 daily deep rTMS treatments

inactive stimulation

20 daily sham deep TMS treatments

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Interventions

H- Coil DTMS

20 daily deep rTMS treatments

Intervention Type: DEVICE

Sham

Intervention Type: DEVICE

Other Intervention Names

H1 coil DTMS; inactive treatment

Eligibility 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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shalvata Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

shalvataMHC

Hod HaSharon, , Israel

Countries

Israel

Central Contacts

Yechiel Levkovich, M.D

Role: CONTACT

ylevk@clalit.org.il

Facility Contacts

Yechiel Levkovich, Prof.

Role: primary

972-9-7478569

Other Identifiers

SHA-14-12

Identifier Type: -

Identifier Source: org_study_id