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

NCT00186485 | Completed Results

• 1 other identifier: Stanford 79133
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS) -17 Item; Baseline to End of Week 4

  The HDRS - 17 is a scale that measures the severity of depression based on the patients response to 17 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 4 (most severe); total scores range from 0 (no depressive symptoms), to 68 (very severe depression). A decrease in the HDRS score reflects a reduction in depression severity.The scores are Baseline and End of Week 4

  4 weeks

Secondary Outcomes (2)

• Beck Depression Inventory Score; Baseline to End of Week 4

  4 weeks

• Clinical Global Impression - Severity; Baseline to End of Week 4

  4 weeks

Study Arms (1)

Right Sided Low Frequency Unilateral TMS

EXPERIMENTAL

1Hz unilateral TMS delivered to the right DLPFC using the MagStim device

Device: MagStim

Interventions

MagStim DEVICE

The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain

Right Sided Low Frequency Unilateral TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Hugh Brent Solvason
• Organization: Stanford University

solvason@stanford.edu

650 776 4793

Study Officials

• Hugh Brent Solvason

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 6, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)