NCT01521052

Brief Summary

Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode. Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 25, 2012

Last Update Submit

January 27, 2012

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Safety of the H1-Coil

    maintaining subject's pre treatment, physical and neurological status.

    One Month

  • Clinical antidepressant response

    a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.

    One Month

Secondary Outcomes (2)

  • Clinical antidepressant remission

    One Month

  • Symptomatic improvement at the end point.

    One Month

Study Arms (1)

elderly depressed patients

EXPERIMENTAL

Twenty seven (27) patients aged 68 years or above, currently suffering from a major depressive episode, who did not respond to treatment with at least one antidepressant medications in the recommended dosage and duration, or could not tolerate at least two antidepressants.

Device: dTMS treatment (H1 Coil)

Interventions

dTMS treatment (H1 Coil)DEVICE

All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.

elderly depressed patients

Eligibility Criteria

Age68 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosed by a senior psychiatrist as suffering from major depression episode according to DSM-IV (either as a part of a unipolar or a bipolar disorder).
  • Rating on HDRS ≥ 20.
  • Age: 68 years and above
  • Treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and ATHF (antidepressant treatment history form) instruction guidelines.
  • Gave informed consent for participation in the study.
  • Negative answers on safety screening questionnaire for TMS.
  • If referred by a treating psychiatrist, he or she approves of the subject's participation in the study.

You may not qualify if:

  • Axis 2 diagnosis, which is considered prominent to the current depressive episode.
  • Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
  • Attempted suicide in the past year.
  • Cognitive impermanent - if MMSE \< 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion
  • History of seizure.
  • History of epilepsy or seizure in first degree relatives.
  • Any CNS disorder that may increase risk of seizure significantly
  • History of a significant 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.
  • Use of hearing aids for hearing loss.
  • Known history of cochlear implants.
  • History of drug abuse or alcoholism.
  • Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Dafna Shefet, MD

CONTACT

972-9-7478524daphnash@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 30, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations

IL(1)