Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression
NCT ID: NCT01469325
Last Updated: 2011-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2011-11-30
2012-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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 rTMS
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
Sham rTMS
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
Interventions
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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 rTMS
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
Eligibility Criteria
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Inclusion Criteria
* Resistance to treatment as defined by the insufficient clinical benefit to at least one adequate medication trials
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Zahra Khazaeipour
Principal Investigator
Locations
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Iranian National Center for Addiction Studies
Tehran, Tehran Province, Iran
Countries
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Central Contacts
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Javad Alaghband-rad, Associate Professor
Role: CONTACT
Phone: +98-9128000036
Email: [email protected]
Facility Contacts
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Zahra Khazaeipour, Community Medicine
Role: primary
Other Identifiers
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90-03-49-14937
Identifier Type: -
Identifier Source: secondary_id
90-03-49-14937
Identifier Type: -
Identifier Source: org_study_id