The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932749
• Other study ID #: 143
• Status: Completed
• Phase: N/A
• First received: August 22, 2013
• Last updated: April 3, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: University of Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Device:
• Transcranial Magnetic stimulation

Locations

Country	Name	City	State
Iran, Islamic Republic of	Atieh neuroscience center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to four weeks	No
Secondary	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.	Test Day 1, 10 & 20	No
Secondary	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	Test Day 1, 10& 20	No
Secondary	Change in QEEG and low resolution brain electromagnetic tomography (LORETA)	QEEG and LORETA is applying for assessment brain waves patterns	Before treatment, immediately after treatment	No