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Completed

NCT Number: NCT01932749

The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atieh neuroscience center

Tehran, Tehran Province, 1969713663, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Other names: Magstim rapid 2

Primary outcomes

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

    Time frame: Baseline to four weeks

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

Secondary outcomes

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

    Time frame: Test Day 1, 10 & 20

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

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

    Time frame: Test Day 1, 10& 20

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

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

    Time frame: Before treatment, immediately after treatment

    QEEG and LORETA is applying for assessment brain waves patterns

Sponsors and collaborators

Lead sponsor

University of Tehran

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2013
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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