Phase 2 Depression and Anxiety Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Bipolar I or II disorder (without psychotic features) according to standard diagnostic guidelines, confirmed by a structured interview, and who are currently going through a depressive episode that started at least 4 weeks before signing consent but no more than 12 months before the screening visit.
• People whose Body Mass Index (BMI) falls between 18.0 and 35.0 kg/m².
• People who are in generally good health, based on a medical history review, physical exam, vital signs, blood tests, and a heart tracing (ECG).
• People whose depression and overall bipolar illness are rated at a certain level of severity (a score of 4 or above on a standard clinical scale) at both the screening and baseline visits.
• People whose manic symptoms are at or below a certain threshold (a score of 12 or less on a standard rating scale) at both the screening and baseline visits.
• People who are currently taking one mood stabiliser only — either lithium, valproate, or lamotrigine — at a stable dose for at least 28 days before screening, and who are able to keep that dose unchanged throughout the study.
• People taking lithium or valproate whose blood levels of that medication fall within the required therapeutic range at screening (lithium: 0.4–1.2 mg/dL; valproate: 50–125 mg/dL).
• People taking lamotrigine whose dose falls within the FDA-accepted range of 50–400 mg/day, where the treating doctor judges the dose to be sufficient to help prevent new mood episodes.

Who may not be able to join:

• People who have had an allergic reaction or significant sensitivity to the study drug, its ingredients, or similar types of medications.
• People who have a current or past medical condition that could interfere with the study, affect how results are interpreted, or put their health at risk — including any unstable condition, a history or current evidence of cancer (except certain treated skin cancers), or significant problems affecting the blood, hormones, heart, lungs, kidneys, liver, digestive system, or nervous system. (Note: if such a condition has been stable for more than one year, does not require any prohibited medications, and the investigating doctor does not believe it would affect participation, the person may still be considered — confirm with trial site.)

Important: Always verify eligibility with the trial site directly before applying.