New drug shows promise for bipolar depression in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (For Bipolar Disorder Depression Patients): * Current diagnosis of bipolar disorder for at least 2 years * DSM-5-TR criteria for bipolar disorder based on Structured Clinical Interview for the DSM-5 - Clinical Trials Version (SCID-5-CT) at Screening * Has a current depressive episode with or without mixed features, but not psychotic features, with duration ≥ 6 weeks and ≤ 24 months * 17-item Hamilton Rating Scale for Depression total score ≥ 22 at Screening and Baseline * Young Mania Rating Scale total score ≤ 12 at Screening and Baseline * For participants who will undergo brain imaging: Able to undergo imaging sessions using Magnetic Resonance Spectroscopy/Imaging with no history of aborted scanning due to anxiety, claustrophobia, or unable to scan due to an incompatible implant/device * Taking at least one mood stabilizer (e.g., lithium, valproate, lamotrigine) and/or second-generation antipsychotic (SGA, atypical antipsychotic). All medications intended to treat the current episode of depression should be at an adequate and stable dose for ≥ 6 weeks prior to screening. Exclusion Criteria (For Bipolar Disorder Depression Patients): * History of \> 4 manic, hypomanic, or depressive episodes within a one-year period (rapid cycler; DSM-5-TR) in the last 2 years * History of schizophrenia or schizoaffective disorder (DSM-5-TR) or a psychotic disorder unrelated to bipolar disorder * Concurrent or history of active symptoms within the past 2 years of obsessive-compulsive disorder, or posttraumatic stress disorder, according to DSM-5-TR criteria * Diagnosis of a personality disorder (DSM-5-TR) * Evident risk of suicide at Screening or Baseline * Inadequate response to more than 2 second-generation antipsychotic treatments (including their current treatment) in their current episode of depression in bipolar disorder despite an adequate dose and duration (\> 6 weeks at approved or standard of care doses) * Received any course of deep brain stimulation in participant's lifetime or plans to receive deep brain stimulation during the study * Treatment with electroconvulsive therapy (for psychiatric/therapeutic purposes) or repetitive transcranial magnetic stimulation, or treatment with ketamine or esketamine for the current episode and received any of those treatments within 12 months prior to Screening * Started new psychotherapy or had a change in the intensity of psychotherapy within 6 weeks before Screening * Prior use of psychedelics for the treatment of depression * Refusal to abstain from consumption of excessive amounts of alcohol during the study * History of uncontrolled, clinically significant neurological (including prior cerebrovascular accident \[stroke\] or chronic seizures), cardiovascular, gastrointestinal, respiratory, renal, hepatic, immunological, hematological, endocrine (including uncontrolled diabetes), or other medical disorder, including cancer * Current use of high dose (\> 4 mg/day lorazepam equivalents) benzodiazepine anxiolytic and/or hypnotic medication * Cannabinoids (marijuana, cannabis, tetrahydrocannabinol \[THC\], cannabidiol \[CBD\]) in any form or use frequency. * History or presence of cataract on ophthalmic examination (including slit-lamp), glaucoma, inflammatory eye disease prior ophthalmic surgical procedures or laser surgery in either eye. Inclusion Criteria (For Healthy Volunteers): * In good health, based on medical history, physical examination (including neurological examination), vital sign measurements, and laboratory safety tests obtained at the Screening Visit * Able to undergo imaging sessions using Magnetic Resonance Spectroscopy/Imaging, with no history of aborted scanning due to anxiety, claustrophobia, or an incompatible implant/device Exclusion Criteria (Healthy Volunteers): * Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit, or is expected to have potential for mental incapacitation during the conduct of the study * History of any illness (including psychiatric illness) * Participation in an investigational drug or device study where last dosing of previous drug is within 30 days * Prior use of psychedelics within the past year * Refusal to abstain from consumption of excessive amounts of alcohol during the study * Cannabinoids (marijuana, cannabis, tetrahydrocannabinol \[THC\], cannabidiol \[CBD\]) in any form or use frequency are not allowed.