Bilateral Accelerated Theta Burst in Treatment-Resistant Bipolar Depression
Trial ID or NCT#
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.
Bilateral Accelerated Theta Burst Stimulation in Treatment-Resistant Bipolar Depression
- - 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.
- - 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.
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Nolan Williams, MD
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