- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01469325
Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Javad Alaghband-rad, Associate Professor
- Phone Number: +98-9128000036
- Email: rad@dal.ca
Study Contact Backup
- Name: Zahra Khazaeipour, Community Medicin
- Phone Number: +98-9125146752
- Email: z_kh14@yahoo.com
Study Locations
-
-
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Tehran, Iran, Islamic Republic of
- Iranian National Center for Addiction Studies
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Contact:
- Zahra Khazaeipour, Community Medicine
- Phone Number: +98-9125146752
- Email: z_kh14@yahoo.com
-
Principal Investigator:
- Javad Alaghband-rad, M.D.
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Principal Investigator:
- Alireza Noroozi, M.D.
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Principal Investigator:
- Zahra Khazaeipour, M.D., MPH.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires.
Time Frame: 3 week
|
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).
|
3 week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90-03-49-14937
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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