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Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression

Primary Purpose

Treatment-Resistant Depression Disease

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham rTMS
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment-Resistant Depression Disease focused on measuring Repetitive Transcranial Magnetic Stimulation, Depression, left prefrontal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV diagnosis of major depression
  • Resistance to treatment as defined by the insufficient clinical benefit to at least one adequate medication trials

Exclusion Criteria:

  • Other current Axis I disorders (except simple phobia and nicotine addiction)
  • Personal or close family history of seizure disorder
  • Ferromagnetic material in body or close to head
  • Neurologic disorder
  • Pregnancy
  • Taking medications known to lower seizure threshold (eg, theophylline)

Sites / Locations

  • Iranian National Center for Addiction Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Repetitive Transcranial Magnetic Stimulation

Sham rTMS

Arm Description

We deliver rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil.

Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.

Outcomes

Primary Outcome Measures

change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires.
The primary outcome measure for the study was score on the MADRS. The patients were assessed with the MADRS, the 17-item version of the Hamilton Depression Rating Scale (HAM-D), the Beck Depression Inventory (BDI), the Brief Psychiatric Rating Scale (BPRS), the CORE Rating of Psychomotor Disturbance (16), and the Global Assessment of Functioning (GAF) Scale (DSM-IVTR).

Secondary Outcome Measures

Full Information

First Posted
November 2, 2011
Last Updated
November 20, 2011
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01469325
Brief Title
Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression
Official Title
Effectiveness of of Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression, in TMS Unit, Neurcognitive Lab, Iranian National Center for Addiction Studies (INCAS), in 2011. A Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Sequential left prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS), with high frequency, for Treatment-Resistant Depression have been shown to have antidepressant effects. but doubts remain about the magnitude of previously demonstrated treatment effects.The aim of this study is To test whether daily weekday left prefrontal rTMS safely and effectively treats Resistant Depression disorder compared to sham controls.
Detailed Description
Design: Prospective, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatment (fixed-dose phase) followed by continued blinded treatment for up to another 3 weeks in improvers. Setting: University psychiatric hospitals in Tehran including Roozbeh Hospital, Rasool Hospital and Imam Hossein General Hospital will refer clients to Iranian National Center for Addiction Studies, Tehran University of Medical Sciences. Patients: About 60 patients with unipolar nonpsychotic major depressive disorder, according to DSM-IV, resistant to treatment. INTERVENTION: We delivered rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-Resistant Depression Disease
Keywords
Repetitive Transcranial Magnetic Stimulation, Depression, left prefrontal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repetitive Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
We deliver rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
Intervention Type
Other
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
We deliver rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil
Intervention Type
Other
Intervention Name(s)
Sham rTMS
Intervention Description
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
Primary Outcome Measure Information:
Title
change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires.
Description
The primary outcome measure for the study was score on the MADRS. The patients were assessed with the MADRS, the 17-item version of the Hamilton Depression Rating Scale (HAM-D), the Beck Depression Inventory (BDI), the Brief Psychiatric Rating Scale (BPRS), the CORE Rating of Psychomotor Disturbance (16), and the Global Assessment of Functioning (GAF) Scale (DSM-IVTR).
Time Frame
3 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of major depression Resistance to treatment as defined by the insufficient clinical benefit to at least one adequate medication trials Exclusion Criteria: Other current Axis I disorders (except simple phobia and nicotine addiction) Personal or close family history of seizure disorder Ferromagnetic material in body or close to head Neurologic disorder Pregnancy Taking medications known to lower seizure threshold (eg, theophylline)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javad Alaghband-rad, Associate Professor
Phone
+98-9128000036
Email
rad@dal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Zahra Khazaeipour, Community Medicin
Phone
+98-9125146752
Email
z_kh14@yahoo.com
Facility Information:
Facility Name
Iranian National Center for Addiction Studies
City
Tehran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahra Khazaeipour, Community Medicine
Phone
+98-9125146752
Email
z_kh14@yahoo.com
First Name & Middle Initial & Last Name & Degree
Javad Alaghband-rad, M.D.
First Name & Middle Initial & Last Name & Degree
Alireza Noroozi, M.D.
First Name & Middle Initial & Last Name & Degree
Zahra Khazaeipour, M.D., MPH.

12. IPD Sharing Statement

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Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression

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