Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Autobahn Therapeutics, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
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
You may not be if
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.
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.
Clareo Health | Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
