Clinical Trials

Inclusion Criteria

General Inclusion Criteria (across all diagnostic groups):

• 18 years and older
• Ability to provide written informed consent
• Adequate cognitive and language abilities to understand and complete study tasks, including clinical assessments and fNIRS procedures
• Confirmed clinical diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment (MCI)
• Stable psychiatric or cognitive condition, without acute episodes requiring immediate intervention

Specific Inclusion Criteria (for diagnostic groups):

• Healthy control
  • No past or current psychiatric or cognitive disorder
• Major depressive disorder (MDD):
  • Diagnosis of major depressive disorder, confirmed through clinical evaluation.
  • No history of bipolar disorder or psychotic symptoms.
• Bipolar disorder:
  • Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.
• Mild Cognitive Impairment (MCI):
  • Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data.
  • No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia.

Exclusion Criteria

General Exclusion Criteria (across all diagnostic groups):

• Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
• Any severe or unstable medical condition that could interfere with participation or data collection
• Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) that could affect cognitive functioning or brain imaging results
• Inability to comply with study procedures, including cognitive testing, fNIRS assessment, or other assessments required by the protocol
• Pregnant women will be excluded due to potential physiological changes that could affect study outcomes

Specific Exclusion Criteria (for diagnostic groups):

• Healthy control
  • Any past or current psychiatric or cognitive disorder
• Major depressive disorder (MDD):
  • Diagnosis of bipolar disorder or schizophrenia.
  • Brain stimulation therapy within the past 3 months.
• Bipolar disorder:
  • Diagnosis of schizophrenia or schizoaffective disorder.
• Mild Cognitive Impairment (MCI):
  • Diagnosis of dementia.
  • Significant cognitive impairment preventing understanding or completion of study tasks.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/22/2024. Questions regarding updates should be directed to the study team contact.