Treatment-Resistant Depression Disease Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment