Recruiting

Emotional Dynamics and Mood Instability in Bipolar Disorder

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Study AimThis study aims to observe and understand the emotional dynamics and mood instability in individuals with bipolar disorder.
What is being tested

Think and Regulate Affective State Task

Behavioral
Who is being recruted

Bipolar Disorder I or II

+ Healthy (Controls)
From 18 to 65 Years
How is the trial designed

Basic Science Study

Interventional
Study Start: November 2025

Summary

Principal SponsorLaureate Institute for Brain Research, Inc.
Study ContactMasaya Misaki Study Primary Investigator, Ph.D.
Last updated: October 28, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2025Actual date on which the first participant was enrolled.

This study is focused on understanding the brain processes involved in the emotional ups and downs experienced by people with bipolar disorder. Individuals with this condition often have rapid and intense mood swings, but the exact brain activities causing these changes are not well understood. This research aims to uncover how the brain shifts between different emotional states and whether increasing positive emotions can help stabilize these mood swings. It is important because it could lead to better ways of managing emotions in people with bipolar disorder, improving their quality of life. Participants in this study include adults with bipolar disorder and healthy individuals for comparison. They undergo two main sessions. The first session involves discussing the study, completing interviews, and filling out questionnaires about their emotions and mood. The second session involves MRI scans that look at brain activity while resting and performing tasks. These tasks include thinking about personal memories and trying to boost positive emotions. The study measures changes in brain activity and emotional responses to understand how emotions fluctuate and whether positive thinking can help manage these changes. This information could help develop future treatments that are more personalized and responsive to the emotional states of those with bipolar disorder.

Official TitleDecoding Emotional Dynamics Driving Mood Instability in Bipolar Disorder 
Principal SponsorLaureate Institute for Brain Research, Inc.
Study ContactMasaya Misaki Study Primary Investigator, Ph.D.
Last updated: October 28, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
72 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bipolar Disorder I or II
Healthy (Controls)
Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.
Study Objectives
Primary Objectives

The decoded emotional state time course derived from fMRI during the Think and Regulate Affective States Task (TReAT). Temporal irregularity will be quantified using permutation entropy to assess emotional state instability in individuals with bipolar disorder compared to healthy controls.

Metastability of brain network states will be calculated from whole-brain fMRI data to characterize variability in emotional states.
Secondary Objectives

Brain regional contributions to the transition energy of emotional brain state changes, derived from network control theory, will be calculated to identify regions that drive transitions between emotional states.

Fractal scaling of brain state changes will be calculated from whole-brain fMRI data to characterize the regularity of emotional brain states.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Laureate Institute for Brain ResearchTulsa, United StatesSee the location

Recruiting
One Study Center