Trial Search Results

Bilateral Accelerated Theta Burst in Treatment-Resistant Bipolar Depression

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. In this open-label study, all participants will receive accelerated theta-burst stimulation.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Bilateral accelerated intermittent theta-burst treatment

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Male or female, 18 to 80 years of age.

   - Able to provide informed consent.

   - Diagnosed with Bipolar Disorder and currently experiencing a Major Depressive Episode
   (MDE).

   - Participants must currently be on a stable and adequate dose of a mood stabilizer and
   medication intake must remain stable throughout study enrollment.

   - Participants may also have a history of intolerance to antidepressant medications.
   These patients with the intolerance history will not be required to be currently
   taking an antidepressant medication.

   - Meet the threshold on the total HAMD17 score of >/=20 at both screening and baseline
   visits (Day -5/-14 and Day 0).

   - Meet the threshold on the BDI-II, with a score of >/=17 at both screening and baseline
   visits (Day -5/-14 and Day 0).

   - Meet the threshold on the total MADRS score of >/=20 at both screening and baseline
   visits (Day -5/-14 and Day 0).

   - In good general health, as ascertained by medical history.

   - If female, a status of non-childbearing potential or use of an acceptable form of
   birth control.

   - History of rTMS failure with FDA approved rTMS parameters is permitted.

   - History of ECT failure or intolerance is permitted.

Exclusion Criteria:

   - Female of childbearing potential who is not willing to use one of the specified forms
   of birth control during the study.

   - Female that is pregnant or breastfeeding.

   - Female with a positive pregnancy test at participation.

   - Total HAMD-17 score of < 20 at the screen or baseline visits.

   - Total MADRS score of < 20 at the screen or baseline visits.

   - Total BDI-II score of < 17 at the screen or baseline visits.

   - Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by
   DSM-IV-TR), with the exception of nicotine dependence.

   - Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized
   Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific
   Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of
   the participant's treatment for the past six months or more).

   - History of schizophrenia or schizoaffective disorders, or any history of psychotic
   symptoms in the current or previous depressive episodes.

   - Any Axis I or Axis II Disorder, which at screening is clinically predominant to their
   bipolar depression or has been predominant to their bipolar depression at any time
   within six months prior to screening.

   - Considered at significant risk for suicide during the course of the study.

   - Has a clinically significant abnormality on the screening examination that might
   affect safety, study participation, or confound interpretation of study results.

   - Participation in any clinical trial with an investigational drug or device within the
   past month or concurrent to study participation.

   - Any current or past history of any physical condition which in the investigator's
   opinion might put the subject at risk or interfere with study results interpretation.

   - History of positive screening urine test for drugs of abuse at screening: cocaine,
   amphetamines, barbiturates, opiates.

   - Current (or chronic) use of opiates.

   - History of epilepsy.

   - History of shrapnel or metal in the head or skull.

   - History of cardiovascular disease or cardiac event.

   - History of OCD.

   - History of autism spectrum disorder.

   - Current psychosis

   - Any change in medication of which the study PI is not aware of.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nolan Williams, MD
Recruiting