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New treatment option for Bipolar Disorder I or II
Official title Decoding Emotional Dynamics in Bipolar Disorder
ClinicalTrials.gov ID: NCT07221864
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- A positive test for drugs of abuse, including alcohol (breath test), cocaine, opiates, amphetamines, methamphetamines, phencyclidine...
- Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol/drug withdrawal, last...
- 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...
See the full eligibility 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)
- 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...
- 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...
- 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...
- Non-correctable vision or hearing problems
The study team makes the final eligibility decision.
Where it's taking place
- Tulsa, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tulsa, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.