The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

N/ACompletedNCT01932749

University of Tehran30 enrolled

Overview

The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic stimulationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Outpatients male and female with the range of 18-65 years of age 2. The diagnosis of Bipolar disorder according to DSM-IV-TR 3. Completion of consent form 4. Being under supervision of a psychiatrist, 5. Having BDI\>14 6. Being able to adhere to treatment schedule, 7. Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks . Exclusion Criteria: 1. The history of rTMS treatment for any reason 2. Intracranial implant and other ferromagnetic materials close to the head 3. Cardiac pacemaker 4. Drug pumps 5. The risk of seizure with any reasons 6. High intracranial pressure 7. The history of epilepsy or seizure in the first relatives 8. Any metal in head 9. Pregnancy 10. Breastfeeding 11. High risk of suicide 12 Having personality disorder in axis II

Locations (1)

Atieh neuroscience center

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Change in depression severity.Depression will be assessed using the Beck depression inventory

The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment.

Time frame: Baseline to four weeks

Secondary Outcomes

Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.

The BAI is measured for anxiety and is administered before treatment, session 10, immediately after treatment.

Time frame: Test Day 1, 10 & 20

Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)

The WHOQOL-BREF is administered for measuring of quality of life before treatment, session 10, immediately after treatment

Time frame: Test Day 1, 10& 20

Change in QEEG and low resolution brain electromagnetic tomography (LORETA)

QEEG and LORETA is applying for assessment brain waves patterns

Time frame: Before treatment, immediately after treatment

Data from ClinicalTrials.gov

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