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

Tehran University of Medical Sciences

Status: Unknown

Conditions: Treatment-Resistant Depression Disease

Treatments: Other: Repetitive Transcranial Magnetic Stimulation; Other: Sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01469325

90-03-49-14937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Repetitive Transcranial Magnetic Stimulation

Active Comparator group

Description:

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.

Treatment:

Other: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

Sham Comparator group

Description:

Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.

Treatment:

Other: Sham rTMS