Status:
RECRUITING
Decoding Emotional Dynamics in Bipolar Disorder
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
National Institutes of Health (NIH)
Conditions:
Bipolar Disorder I or II
Healthy (Controls)
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Detailed Description
This neuroimaging study investigates the neural mechanisms underlying emotional dynamics and mood instability in individuals with bipolar disorder (BD). Bipolar disorder is characterized by rapid and ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)
- Exclusion Criteria
- No telephone or easy access to a telephone
- 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
- 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.
- 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)
- Current significant suicidal ideation or suicide attempt within the past 3 months.
- 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)
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07221864
Start Date
November 1 2025
End Date
November 1 2028
Last Update
October 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74135