Clinical trial NCT01469325: Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment-Resistant Depression Disease
Keywords: Repetitive Transcranial Magnetic Stimulation
Depression
left prefrontal
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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)

Primary outcomes:
measure: change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires.
timeFrame: 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iranian National Center for Addiction Studies
Study officials:
References: