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

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.

Study Overview

• Status: Unknown
• Conditions: Treatment-Resistant Depression Disease
• Intervention / Treatment: Other: Repetitive Transcranial Magnetic Stimulation; Other: Sham rTMS

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Iranian National Center for Addiction Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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
Sham Comparator: Sham rTMS; 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; Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: November 2, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (Estimate): November 10, 2011

Study Record Updates

• Last Update Posted (Estimate): November 22, 2011
• Last Update Submitted That Met QC Criteria: November 20, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Depression; Repetitive Transcranial Magnetic Stimulation; left prefrontal
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: 90-03-49-14937