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NCT04696471Completed

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

Elucidating Neural Mechanisms of Hypo/Mania Using Theta Burst Stimulation

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood. Here, the investigators aim to examine the immediate effect of transcranial brain stimulation (TBS) on brain activity and emotions in adults with and without BD as a first stage toward understanding the predisposing brain mechanisms of BD. The investigators hypothesize that TBS will reduce brain activity while playing a game with rewards in all adults, but the TBS will reduce brain activity more in the adults with BD compared to adults without BD. Furthermore, the investigators hypothesize that this reduced brain activity will be associated with reduced BD symptoms, such as negative emotions.

Status (registry)
Completed
Study type
Interventional
Enrollment
146 (actual)
First submitted
18 Dec 2020
Start date
6 Apr 2021
Primary completion date
24 Oct 2025
Lead sponsor
Mary Phillips, MD MD (Cantab)
NCT number
NCT04696471

What you commit to

  • Study type: Interventional
  • Participants enrolled: 146
  • From 6 Apr 2021 to the primary completion date, 24 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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
  • Participants without Bipolar Disorder
    • Present/ lifetime history of any psychiatric disorder other than anxiety and non BD mood disorders
    • Family history of of BD

Who the study is looking for

  • 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
  • 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, as these are commonly-prescribed medications for BD
  • 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

Age in the registry: 18 years to 35 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pittsburgh
Coordinator of this site? Confirm its status		PittsburghUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.