Bipolar Depression Research Study – Screening Questionnaire

Full Name

Email Address

Phone Number

Date of Birth

Format: Month/Day/Year (e.g., 01/15/1990)

City and State You Live In

Do you consent to be contacted about future research studies?

Yes No

What types of studies would you be interested in?

List comma separated keywords

Height (in inches):

Height and weight are used to compute BMI; eligibility requires BMI between 18.0 and 35.0.

Approximate weight (in pounds):

Are you willing and able to comply with study visits, procedures, blood draws, ECGs, and medication requirements?

Yes No

Have you been diagnosed with Bipolar I or Bipolar II disorder without psychotic features?

Yes No

Is Bipolar I or II disorder your primary condition currently being treated?

Yes No

Are you currently experiencing a depressive episode that began at least 4 weeks ago but has not exceeded 6 months?

Yes No

During this depressive episode, have you experienced hallucinations or psychotic features?

Yes No

Have you had a psychiatric hospitalization (inpatient or intensive outpatient) within the past 3 months?

Yes No

Have you ever been diagnosed with any of the following? (Select all that apply)

Schizophrenia or other psychotic disorder Dissociative disorder Neurocognitive disorder Opioid use disorder None of the above

In the past 12 months, have you been diagnosed with or treated for any of the following?

ADHD Personality disorder PTSD OCD Eating disorder (anorexia, bulimia, binge eating) None of the above

Would you describe your current depression as moderate to severe?

Yes No

Are you currently experiencing a significant loss of interest or pleasure in activities you usually enjoy (anhedonia)?

Yes No

Are you currently taking ONE of the following mood stabilizers?

Lithium Valproate (Depakote) Lamotrigine (Lamictal) None of the above

Have you been on a stable dose of this medication for at least 28 days?

Yes No

Are you willing to remain on a stable dose of your mood stabilizer throughout the study?

Yes No

Have you failed (had little or no benefit from) 3 or more antidepressant medications during your current depressive episode?

Yes No

Have you started psychotherapy within the past 8 weeks?

Yes No

Have you received any experimental or investigational central nervous system (CNS) treatment within the past 12 months?

Yes No

In the past 6 months, have you had thoughts of suicide with intent or a specific plan?

Yes No

In the past 12 months, have you attempted suicide or engaged in suicidal behavior?

Yes No

In the past 12 months, have you had a moderate or severe substance use disorder (excluding nicotine)?

Yes No

Have you used opioids (prescribed or recreational) within the past 2 weeks?

Yes No

Would you be willing to complete drug and alcohol testing as part of the study?

Yes No

Are you willing to abstain from cannabis use during the study if required?

Yes No

Do you have any unstable or serious medical conditions?

Yes No

Have you been diagnosed with liver, kidney, heart, neurological, endocrine, or gastrointestinal disease that is not stable?

Yes No

Have you used an investigational drug within the past 30 days?

Yes No

Are you currently taking strong CYP3A inhibitors or inducers?

Yes No

Have you consumed grapefruit or grapefruit juice within the past 14 days?

Yes No

What is your sex at birth?

Male Female

Are you currently pregnant or breastfeeding?

Yes No

If you are of childbearing potential, are you willing to use an approved method of birth control during the study and for 30 days after?

Yes No Not applicable

If you are sexually active with a female partner of childbearing potential, are you willing to use protocol-required contraception during the study and for 30 days after?

Yes No Not applicable