NCT01932749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

August 22, 2013

Last Update Submit

April 3, 2014

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

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

    Test Day 1, 10 & 20

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

    Test Day 1, 10& 20

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

    Before treatment, immediately after treatment

Study Arms (2)

bilateral repetitive transcranial magnetic stimulation

ACTIVE COMPARATOR

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

Device: Transcranial Magnetic stimulation

unilateral repetitive transcranial magnetic stimulation

ACTIVE COMPARATOR

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

Device: Transcranial Magnetic stimulation

Interventions

Transcranial Magnetic stimulationDEVICE
Also known as: Magstim rapid 2
bilateral repetitive transcranial magnetic stimulationunilateral repetitive transcranial magnetic stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atieh neuroscience center

Tehran, Tehran Province, 1969713663, Iran

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

IR(1)