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Magnetic brain zap reveals clues to bipolar mood swings

NCT ID NCT04696471

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study used a non-invasive brain stimulation technique called theta burst stimulation (TMS) to explore how the brain processes rewards in people with bipolar disorder. Researchers compared brain scans before and after stimulation in 146 adults, both with and without bipolar disorder, while they played a reward-based game. The goal was to identify brain activity patterns linked to mood swings, which could lead to better understanding and future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Continuous Theta Burst Stimulation (cTBS) via Transcranial Magnetic Stimulation (TMS)
What this could lead to
If successful, this research could help explain the brain mechanisms behind mood swings in bipolar disorder, potentially pointing toward new treatment targets.
What could go wrong
This is an early-stage, completed study focused on understanding brain activity, not testing a treatment. The results may not directly lead to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

146 people

The number who actually took part.

Started

Apr 2021

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.