Recruiting

Bipolar Disorder

Sponsor:

Laureate Institute for Brain Research, Inc.

Code:

NCT07221864

Conditions

Bipolar Disorder I or II

Healthy (Controls)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Think and Regulate Affective State Task

Study Details

Brief summary:

The goal of this neuroimaging study is to investigate how emotional states fluctuate in people with bipolar disorder (BD) compared to healthy controls, and to understand the neural mechanisms driving mood instability. The main questions it aims to answer are:

  • Can emotional states be decoded from fMRI brain activity using machine learning?
  • Do individuals with BD show more unstable emotional state trajectories (e.g., high metastability, low fractal scaling) than healthy controls?
  • Does amplifying positive emotions stabilize brain and emotional dynamics in BD?

Researchers will compare individuals with bipolar disorder (BD-I or BD-II, currently depressed or mixed state) to healthy controls without psychiatric history to see whether the BD group shows greater fluctuations in emotional brain activity and whether positive emotion regulation strategies normalize this instability.

Participants will:

  • Complete self-report questionnaires on mood, emotion regulation, anxiety, and daily functioning.
  • Recall and provide short descriptions of personal positive and negative memories to be used in the MRI task.
  • Undergo fMRI scanning, including:
  • Resting-state scans
  • A Think and Regulate Affective States Task (TReAT) where they recall autobiographical memories, rate emotions, and practice amplifying positive mood.
  • Structural and diffusion MRI for brain mapping.
  • Receive physiological monitoring (heart rate, respiration) during scanning.
  • Complete post-scan surveys on emotional state and task experience.

This research will help clarify how the brain supports or disrupts emotional regulation in bipolar disorder and may inform the development of personalized, neurobiologically informed treatments for mood instability.

Conditions

Bipolar Disorder I or II

Healthy (Controls)

Study ID

NCT07221864

Start date

Oct 30, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria

1. Age 18 to 65 years
2. Male or female
3. BMI between 18.5 and 38.0 kg/m2 at Screening
4. Capable of understanding and complying with study requirements
5. Fluent in English
6. Able to provide informed consent

BD Group:
7. Meet the DSM-5 diagnostic criteria for BD-I or BD-II who are currently depressed or mixed state defined by the Mini-International Neuropsychiatric Interview (MINI)
8. Moderate or greater depressive symptom severity (MADRS ≥ 15 or PHQ-9 ≥ 10)

HC Group:
9. No current or past psychiatric disorder (verified by MINI)

Exclusion Criteria

1. No telephone or easy access to a telephone
2. Significant medical problems as identified by the medical screening questionnaire: e.g. a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
3. A positive test for drugs of abuse, including alcohol (breath test), cocaine, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone
4. Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol/drug withdrawal, last cannabis use must be >48 hours prior to study session.
5. Current DSM-5 diagnosis of a psychosis spectrum disorder or moderate to severe substance use disorder
6. Moderate to severe traumatic brain injury or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider)
7. Current significant suicidal ideation or suicide attempt within the past 3 months.
8. Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning, e.g., anxiolytics, antipsychotics, antidepressants, or mood stabilizers
9. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day)
10. MRI contraindications as documented on the MR Environment Screening
11. Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia), or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task)
12. Non-correctable vision or hearing problems

Study Design

Enrollment

72 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Decoding Emotional Dynamics

All participants complete the same two-session protocol: a preparation visit with diagnostic interviews and questionnaires, followed by an MRI session including resting-state and task-based scans. During the Think and Regulate Affective States Task (TReAT), participants recall personal positive and negative memories, rate their emotions, and practice positive emotion amplification strategies. Physiological signals are recorded throughout. Both individuals with bipolar disorder and healthy controls complete identical procedures for comparison of brain and emotional dynamics.

Interventions

Think and Regulate Affective State Task

Participants complete the Think and Regulate Affective States Task (TReAT) during fMRI scanning. This task presents brief cues of participants' own autobiographical memories, four positive and four negative, to evoke corresponding emotional states. While viewing these cues, participants alternate between thinking about the memory, rating emotional valence and arousal, and practicing positive emotion amplification strategies. Each session includes multiple blocks of "Think," "Rate," "Regulate," "Attention," and "Rest" periods. Physiological measures (heart rate and respiration) are recorded concurrently. The task is designed to decode emotional states from fMRI data and evaluate the neural impact of positive emotion regulation in bipolar disorder compared to healthy controls.

Primary outcome measure

  • Decoded Emotional State Trajectory [ Time Frame: Day 2 ]
  • Metastability of brain network states [ Time Frame: Day 2 ]

Central Contacts and Locations

Central contacts

Masaya Misaki Study Primary Investigator, Ph.D.

918-502-5137mmisaki@laureateinstitute.org

Locations

Laureate Institute for Brain Research

Recruiting

Tulsa, Oklahoma, United States, 74135

Contacts

Principal Investigator:

Masaya Misaki, Ph.D.

More Information

Sponsor

Laureate Institute for Brain Research, Inc.

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • neuroimaging
  • fMRI
  • Bipolar Disorder I
  • Bipolar Disorder II
  • machine learning
  • emotion regulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Laureate Institute for Brain Research, Inc. on 2026-04-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.