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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Tehran University of Medical Sciences.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Zahra Khazaeipour, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01469325
First received: November 2, 2011
Last updated: November 20, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Treatment-Resistant Depression Disease
Other: Repetitive Transcranial Magnetic Stimulation
Other: Sham rTMS

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

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires. [ Time Frame: 3 week ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Repetitive Transcranial Magnetic Stimulation
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.
Other: Repetitive Transcranial Magnetic Stimulation
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 Comparator: Sham rTMS
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
Other: Sham rTMS
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT01469325

Contacts
Contact: Javad Alaghband-rad, Associate Professor +98-9128000036 rad@dal.ca
Contact: Zahra Khazaeipour, Community Medicin +98-9125146752 z_kh14@yahoo.com

Locations
Iran, Islamic Republic of
Iranian National Center for Addiction Studies Recruiting
Tehran, Iran, Islamic Republic of
Contact: Zahra Khazaeipour, Community Medicine    +98-9125146752    z_kh14@yahoo.com   
Principal Investigator: Javad Alaghband-rad, M.D.         
Principal Investigator: Alireza Noroozi, M.D.         
Principal Investigator: Zahra Khazaeipour, M.D., MPH.         
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Zahra Khazaeipour, Principal Investigator, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01469325     History of Changes
Other Study ID Numbers: 90-03-49-14937, 90-03-49-14937
Study First Received: November 2, 2011
Last Updated: November 20, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
Repetitive Transcranial Magnetic Stimulation
Depression
left prefrontal

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014