CClinicalTrials.gg
CompletedNCT00807105Updated Jan 5, 2012

Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode

A Phase 2 interventional study of H-coil dTMS in Major Depressive Disorder, sponsored by Shalvata Mental Health Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-01-05.

Sponsored by Shalvata Mental Health Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a prospective open label study of acute and maintenance treatment of MDD. The acute phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight weeks followed by 10 weeks of once a week treatments.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • MOOD EVALUATION
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 29 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Shalvata Mental Health Center is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • MDD patients

Exclusion criteria

Exclusion Criteria:

  • risk factors for convulsions
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    depressive patients

    patients suffering from deppresion

    Device: H-coil dTMS

Interventions

  • DeviceH-coil dTMS

    treatment with deep TMS stimulation.

06

What researchers measure

Primary outcomes

  1. response in HAMDS

    Time frame: 1 YEAR

07

Study locations

1 site
  • ShalvataMHC
    Hod Hasharon, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00807105
Lead sponsor
Shalvata Mental Health Center
Collaborators
Brainsway
Responsible party
Sponsor
First posted
Dec 11, 2008
Start date
Jun 2008
Primary completion
May 2010
Completion
May 2010
Last update
Jan 5, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion