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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Treatment-Resistant Depression Disease

Intervention / Treatment
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* Other: Repetitive Transcranial Magnetic Stimulation
* Other: Sham rTMS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Repetitive Transcranial Magnetic Stimulation<br>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<br>* 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<br>|
| Sham Comparator: Sham rTMS<br>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<br>* Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repetitive Transcranial Magnetic Stimulation, Depression, left prefrontal