Effects of Theta Burst Stimulation on the Brain, Behavior, and Clinical Symptoms in Adults With Bipolar Disorder

Launched by MARY PHILLIPS, MD MD (CANTAB) · Jan 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Theta Burst Stimulation (TBS) to see how it affects brain activity, emotions, and symptoms in adults with Bipolar Disorder (BD). Researchers believe that TBS may help reduce brain activity while playing a reward-based game, and they want to find out if this effect is stronger in people with BD compared to those without the condition. The goal is to better understand the brain processes involved in BD and how TBS might help reduce negative emotions and other symptoms associated with the disorder.

To participate in this trial, individuals must be between 18 and 35 years old. Those with Bipolar Disorder should have a diagnosis of either Bipolar I or II and be in a stable condition, meaning their symptoms are not severe at the moment. Participants without BD should not have any history of psychiatric disorders other than some anxiety or mild mood issues. Throughout the trial, participants will engage in brain scans and other assessments to monitor the effects of TBS. It's important to note that certain medical history factors, including severe mental health issues or substance use, may prevent someone from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. All participants
• • 18-35 years of age
• • Scoring less than or equal to 8 on the Hamilton Rating Scale for Depression (HRSD) at screen visit
• • 2. Participants with Bipolar Disorder (BD)
• • Diagnosis of Bipolar Disorder I/II (BDI/II) (DSM-5 criteria) in remission (euthymic for \>2 months) or with mild-moderate hypomania
• • \<15 on the Young Mania Rating Scale
• • Not psychotic
• • \<3 on delusions, hallucinations, unusual thought content, and conceptual disorganization items of the Positive and Negative Syndrome Scale (PANSS)
• • Unmedicated or on any combination (except antidepressant monotherapy) of anxiolytics (benzodiazepines, buspirone, pregabalin, hydroxyzine) as needed, and/or atypical antipsychotics, and/or lithium, and/or other mood stabilizers, and/or non-SNRI antidepressants and/or non benzodiazepine hypnotics taken for \>2 months, as these are commonly-prescribed medications for BD
• • 3. Participants without Bipolar Disorder
• • No present or lifetime history of BD or psychiatric disorder other than anxiety or non BD mood disorders
• • Not in a current depressive episode
• • No family history of BD
• Exclusion Criteria:
• • 1. All participants
• • History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
• • Family history of epilepsy (TBS exclusion criterion)
• • Use of substances with seizure risk (e.g., stimulants) in the past month, assessed as at screening, baseline, and before each fMRI-cTBS-fMRI session
• • Mini-Mental State Examination score (cognitive state) \<24
• • Premorbid National Adult Reading Test Intelligent Quotient estimate\<85
• • Visual disturbance: \<20/40 Snellen visual acuity
• • Left/mixed handedness
• • History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (\<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals
• • Binge drinking in the week before, and/or \>3 units/day for the 3 days before, and/or alcohol in the last 12 hrs before, any cTBS scan day, confirmed at screening and scan days (to avoid TBS during alcohol withdrawal). Alcohol/nicotine/ caffeine/cannabis use (below SCID-5 SUD, binge levels) will be allowed, and used as covariates
• • MRI exclusion criteria: metallic objects, e.g., surgical implants; claustrophobia; proneness; positive pregnancy test for females (performed at the MRRC) or self-report pregnancy
• • Inability to understand English
• • \<18 years of age or \>35 year of age
• • SNRI antidepressants and bupropion will not be allowed, as they can elevate seizure risk, a contraindication for TBS
• • Scoring greater than or equal to 8 on HRSD and in depressive episode is confirmed on SCID-5 at screen visit
• • Scoring greater than or equal to 18 on HRSD at any visit
• • In current depressive episode
• • 2. Participants with Bipolar Disorder
• • BD diagnosis other than BDI/II
• • More severe hypo/mania (YMRS\>15)
• • Psychosis
• • Using psychotropic medications other than those allowed in inclusion criteria
• • 3. Participants without Bipolar Disorder
• • Present/ lifetime history of any psychiatric disorder other than anxiety and non BD mood disorders
• • Family history of of BD