The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

Not Applicable

Completed

• Conditions: Bipolar Disorder
• Interventions: Device: Transcranial Magnetic stimulation

• Registration Number: NCT01932749
• Lead Sponsor: University of Tehran

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilateral repetitive transcranial magnetic stimulation	Transcranial Magnetic stimulation	Bilateral protocol: Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/
unilateral repetitive transcranial magnetic stimulation	Transcranial Magnetic stimulation	Unilateral protocol: Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain

Primary Outcome Measures

Name	Time	Method
Change in depression severity.Depression will be assessed using the Beck depression inventory	Baseline to four weeks	The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment.

Secondary Outcome Measures

Name	Time	Method
Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)	Test Day 1, 10& 20	The WHOQOL-BREF is administered for measuring of quality of life before treatment, session 10, immediately after treatment
Change in QEEG and low resolution brain electromagnetic tomography (LORETA)	Before treatment, immediately after treatment	QEEG and LORETA is applying for assessment brain waves patterns
Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.	Test Day 1, 10 & 20	The BAI is measured for anxiety and is administered before treatment, session 10, immediately after treatment.

Trial Locations

Locations (1)

Atieh neuroscience center; 🇮🇷 Tehran, Iran, Islamic Republic of