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The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Transcranial Magnetic stimulation
Sponsored by
University of Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atieh neuroscience center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

bilateral repetitive transcranial magnetic stimulation

unilateral repetitive transcranial magnetic stimulation

Arm Description

Bilateral protocol: Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/

Unilateral protocol: Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Change in QEEG and low resolution brain electromagnetic tomography (LORETA)
QEEG and LORETA is applying for assessment brain waves patterns

Full Information

First Posted
August 22, 2013
Last Updated
April 3, 2014
Sponsor
University of Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT01932749
Brief Title
The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression
Official Title
The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tehran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bilateral repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
Bilateral protocol: Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/
Arm Title
unilateral repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
Unilateral protocol: Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic stimulation
Other Intervention Name(s)
Magstim rapid 2
Primary Outcome Measure Information:
Title
Change in depression severity.Depression will be assessed using the Beck depression inventory
Description
The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment.
Time Frame
Baseline to four weeks
Secondary Outcome Measure Information:
Title
Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.
Description
The BAI is measured for anxiety and is administered before treatment, session 10, immediately after treatment.
Time Frame
Test Day 1, 10 & 20
Title
Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)
Description
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
Title
Change in QEEG and low resolution brain electromagnetic tomography (LORETA)
Description
QEEG and LORETA is applying for assessment brain waves patterns
Time Frame
Before treatment, immediately after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients male and female with the range of 18-65 years of age The diagnosis of Bipolar disorder according to DSM-IV-TR Completion of consent form Being under supervision of a psychiatrist, Having BDI>14 Being able to adhere to treatment schedule, Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks . Exclusion Criteria: The history of rTMS treatment for any reason Intracranial implant and other ferromagnetic materials close to the head Cardiac pacemaker Drug pumps The risk of seizure with any reasons High intracranial pressure The history of epilepsy or seizure in the first relatives Any metal in head Pregnancy Breastfeeding High risk of suicide 12 Having personality disorder in axis II
Facility Information:
Facility Name
Atieh neuroscience center
City
Tehran
ZIP/Postal Code
1969713663
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

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