NCT07221864Recruiting
Decoding Emotional Dynamics in Bipolar Disorder
Decoding Emotional Dynamics Driving Mood Instability in Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 23 Oct 2025
- Start date
- 30 Oct 2025
- Primary completion date
- Nov 2028
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Diseases
- Bipolar disorder
- NCT number
- NCT07221864
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 30 Oct 2025 to the primary completion date, Nov 2028
- 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
- A positive test for drugs of abuse, including alcohol (breath test), cocaine, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone
- 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.
- 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
- Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake \> 1000 mg/day)
Other illness
- 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
- Current DSM-5 diagnosis of a psychosis spectrum disorder or moderate to severe substance use disorder
- 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)
Other
- No telephone or easy access to a telephone
- Current significant suicidal ideation or suicide attempt within the past 3 months.
- MRI contraindications as documented on the MR Environment Screening
- 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)
- Non-correctable vision or hearing problems
Who the study is looking for
- Age 18 to 65 years
- Male or female
- BMI between 18.5 and 38.0 kg/m2 at Screening
- Capable of understanding and complying with study requirements
- Fluent in English
- Able to provide informed consent
- BD Group:
- 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)
- Moderate or greater depressive symptom severity (MADRS ≥ 15 or PHQ-9 ≥ 10)
- HC Group:
- No current or past psychiatric disorder (verified by MINI)
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laureate Institute for Brain Research Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.