Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients

National Autonomous University of Mexico ( UNAM )

Status and phase: Unknown; Phase 4

Conditions: Major Depression

Treatments: Device: Sham Transcranial Magnetic Stimulation; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02213016

141-2011

Details and patient eligibility

About

The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three months.

Full description

This is a randomized, double-blinded, placebo-controlled, parallel group clinical trial to evaluate the efficacy of two Transcranial Magnetic Stimulation (TMS) protocols in patients with major depressive disorder (MDD). 70 ambulatory patients with a MDD diagnosis from the Clinic at the Department of Psychiatry and Mental Health at the Universidad Nacional Autónoma de México (UNAM) will be included. All Patients will complete a total of 15 sessions of treatment in any of four groups: A group of patients will be randomly assigned to receive either 5 active TMS sessions or 2 sessions per week. Sham controls will also be randomly assigned to receive either 5 TMS sessions or 2 sessions per week. Afterwards, all participants will receive 2 sessions per month for a 3 month period. Depressive and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of a 3-month follow up. In addition, neuropsychological evaluations will be applied at baseline and at the end of the 15 session's treatment. Sessions will be applied with a MAG pro x 100 transcranial magnetic stimulator. Motor threshold will be set. Sessions will be applied over the left DLPFC at 5 Hz, 30 trains, 100%. Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety and depressive symptom scale scores between treatment groups will be compared using repeated measures ANOVA.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of major depressive disorder
• Having a greater or equal score to 18 points in the Ham-D scale at the moment of the initial evaluation
• Treatment free patients

Exclusion criteria

• Epilepsy or seizure risk record
• Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 4 patient groups

Transcranial magnetic stimulation

Sham Comparator group

Description:

Sham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.

Treatment:

Device: Sham Transcranial Magnetic Stimulation

Transcraneal magnetic stimulation

Active Comparator group

Description:

Active repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.

Treatment:

Device: Transcranial Magnetic Stimulation

Sham Comparator

Sham Comparator group

Description:

Sham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.

Treatment:

Device: Sham Transcranial Magnetic Stimulation

Active Comparator

Active Comparator group

Description:

Active repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.

Treatment:

Device: Transcranial Magnetic Stimulation