Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186485
First received: September 14, 2005
Last updated: December 14, 2007
Last verified: December 2007

September 14, 2005
December 14, 2007
May 2003
Not Provided
MADRS
Not Provided
Complete list of historical versions of study NCT00186485 on ClinicalTrials.gov Archive Site
BDI, CGI
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Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Bipolar Depression
Safety and Efficacy of Open Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Bipolar Depression

We hope to learn whether this stimulation of neurons in the front part of the brain may relieve depression.

The primary objective of this study is to examine the safety and efficacy of rTMS in the management of treatment-resistant bipolar depression.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
Device: MagStim
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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Inclusion Criteria:Inclusion Criteria:

  • DSM IV Bipolar I or II Disorder with current major depressive episode
  • Prior failure to respond to or tolerate at least 2 adequate pharmacotherapy trials
  • Ham-D score greater than or equal to 18

Note: site enrolls only one patient per month Exclusion Criteria:Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption); b. Individuals diagnosed by the investigator with the following conditions (current unless other-wise stated): Depression secondary to a general medical condition, or substance-induced; Seasonal pattern of depression as defined by DSM-IV, History of substance abuse or dependence within the past year (except nicotine and caffeine); Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes; Obsessive compulsive disorder (lifetime); or Post-traumatic stress disorder (current or within the past year). c. An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol. d. Individuals with a clinically defined neurological disorder or insult including, but not limited to: Any condition likely to be associated with increased intracranial pressure; Space occupying brain lesion; Any history of seizure EXCEPT those therapeutically induced by ECT; History of cerebrovascular accident; Transient ischemic attack within two years; Cerebral aneurysm; Dementia; Mini Mental Status Exam (MMS) score of <24; Parkinson#s disease; Huntington#s chorea; or Multiple sclerosis.

e. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for >5 minutes; f. A true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire (see Attachment H) g. Lifetime treatment with more than 12 antidepressant medication trials, at any dose or duration, either monotherapy or combination therapy from the list summarized in Attachment I. h. ECT treatment within 3 months prior to the screening visit; i. Failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher) in this or any previous j. History of treatment with rTMS therapy for any disorder; k. History of treatment with Vagus Nerve Stimulation; l. Use of any investigational drug within 4 weeks of the randomization visit; m. Use of fluoxetine within 6 weeks of the randomization visit; n. Use of an MAOI within 2 weeks of the randomization visit; o. Use of any medication(s) listed on the Excluded Medication List (Attachment J) within 1 week of the randomization visit; p. Significant acute suicide risk, defined as follows: Suicide attempt within the previous 6 months that required medical treatment; or >2 suicide attempts in the past 12 months; or Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator#s opinion, is likely to attempt suicide within the next 6 months. q. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease; r. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;s. Known or suspected pregnancy; t. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial; u. Positive urine drug screen. (A positive urine drug screen at screening may be repeated once prior to randomization); v. Clinically significant laboratory abnormality, in the opinion of the investigator; w. Women who are breast-feeding; x. Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00186485
Stanford 79133
Not Provided
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Stanford University
Not Provided
Principal Investigator: Hugh Brent Solvason Stanford University
Stanford University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP