The Comparison of effectiveness of Bilateral repetitive transcranial magnetic stimulation Versus Unilateral repetitive transcranial magnetic stimulation 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 depression. 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 inclusion criteria are included BDI-II score >14 and diagnosis of Bipolar disorder according to DSM-IV-TR.The exclusion criteria areincluded risk of Seizure with any reasons and cardiac Pacemaker. The Depressive symptoms, anxiety symptoms, quality of life and qEEG will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308204191N2
Registration date:2013-09-08, 1392/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-08, 1392/06/17
Registrant information
Name
Reza Kazemi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8401 2128
Email address
rezakazemi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Atieh Neuroscience Center
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of effectiveness of Bilateral repetitive transcranial magnetic stimulation Versus Unilateral repetitive transcranial magnetic stimulation in Patients with Bipolar Depression: a study randomized and Single blind
Public title
The Study of effectiveness of repetitive transcranial magnetic stimulation in Patients with Bipolar Depression
Purpose
Treatment
Inclusion/Exclusion 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; BDI-II score >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, acute heart attack; having personality disorders in Axis II; The risk of Seizure with any reasons, high Intracranial pressure, The history of epilepsy or Seizure in the first relatives, any metal in Head, brain trauma, history of loss of consciousness for more than 5 minutes; Pregnancy, breastfeeding; High risk of Suicide.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
www.clinicaltrials.gov
Secondary trial Id
NCT01932749
Registration date
2013-08-22, 1392/05/31
Ethics committees
1
Ethics committee
Name of ethics committee
University Of Tehran
Street address
Faculty of Psychology & Education University of Tehran Jalal Al-e-Ahmad Ave.
City
Tehran
Postal code
Approval date
2013-05-25, 1392/03/04
Ethics committee reference number
92/33736
Health conditions studied
1
Description of health condition studied
Bipolar Depression
ICD-10 code
F31.4
ICD-10 code description
Bipolar affective disorder, current episode severe depression without psychotic symptoms
Primary outcomes
1
Description
Bipolar Depression
Timepoint
Befor intervention, ten Session, after intervention