- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932749
The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression
April 3, 2014 updated by: reza kazemi, University of Tehran
The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of, 1969713663
- Atieh neuroscience center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: bilateral repetitive 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/ |
Other Names:
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Active Comparator: unilateral repetitive transcranial magnetic stimulation
Unilateral protocol: Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain |
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depression severity.Depression will be assessed using the Beck depression inventory
Time Frame: Baseline to four weeks
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The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment.
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Baseline to four weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.
Time Frame: Test Day 1, 10 & 20
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The BAI is measured for anxiety and is administered before treatment, session 10, immediately after treatment.
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Test Day 1, 10 & 20
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Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)
Time Frame: Test Day 1, 10& 20
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The WHOQOL-BREF is administered for measuring of quality of life before treatment, session 10, immediately after treatment
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Test Day 1, 10& 20
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Change in QEEG and low resolution brain electromagnetic tomography (LORETA)
Time Frame: Before treatment, immediately after treatment
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QEEG and LORETA is applying for assessment brain waves patterns
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Before treatment, immediately after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
August 22, 2013
First Submitted That Met QC Criteria
August 27, 2013
First Posted (Estimate)
August 30, 2013
Study Record Updates
Last Update Posted (Estimate)
April 7, 2014
Last Update Submitted That Met QC Criteria
April 3, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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