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

Not Applicable

• Conditions: Treatment-Resistant Depression Disease
• Interventions: Other: Sham rTMS; Other: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT01469325
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-10
• Last Update Submitted: 2011-11-20
• Last Update Posted: 2011-11-22
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	Sham rTMS	Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
Repetitive Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires.	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).

Trial Locations

Locations (1)

Iranian National Center for Addiction Studies; 🇮🇷 Tehran, Iran, Islamic Republic of