NCT06869187进行中（未招募）2 期
A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 in Adults With Bipolar Disorder Experiencing an Episode of Depression
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 25
- 主要终点
- Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17)
研究概览
简要总结
The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment(s) can improve clinical symptoms of depression and to learn about potential effects on brain chemistry that may correlate with antidepressive effects.
This is a single treatment arm, open-label, Phase 2 study of ABX-002 in up to30 adults with bipolar depression. A subset of these participants will undergo brain imaging. Five healthy volunteer participants will also be enrolled and receive no drug treatment, undergoing 2 imaging sessions to confirm instrument and test - retest method reliability control.
For bipolar disorder participants who are experiencing an episode of depression, the study will include 4 study periods:
- Screening Period of up to 5 weeks
- 6-week Treatment Period
- 2-week post dose Safety Follow-up Period.
- 6-month postdose targeted safety follow-up period
For healthy volunteers, the study will include 2 study periods:
- Screening Period of up to 3 weeks
- Imaging Period of up to 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
ABX-002 + at least one mood stabilizer and/or single second-generation antipsychotic (SGA)
Experimental
Participants will continue all medications intended to treat the current episode of depression for the duration of the study in addition to ABX-002
干预措施: ABX-002 (Drug)
结局指标
主要结局
Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17)
时间窗: Weeks 6
HAMD-17 is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.
次要结局
- Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)(Weeks 6)
- Correlation of change from baseline in the anterior cingulate cortex (ACC) nucleoside triphosphate/inorganic phosphate (NTP/Pi) concentrations with percentage change in Hamilton Depression Rating Scale (HAMD)-17(Week 6)
- Correlation of change from Baseline in the anterior cingulate cortex (ACC) phosphocreatine/inorganic (PCr/Pi) concentration with percentage change in Hamilton Depression Rating Scale (HAMD)-17(Week 6)
- Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)(Weeks 6)
- Change from baseline in 6-item Hamilton Rating Scale for Depression (HAMD-6)(Weeks 6)
研究者
研究点 (25)
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