ABX-002 for Bipolar Depression

Recruiting at -1 trial locations

Overseen By Regina Griffin, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Autobahn Therapeutics, Inc.

Must be taking: Mood stabilizers, Atypical antipsychotics

Must not be taking: High dose anxiolytics

Disqualifiers: Rapid cycler, Schizophrenia, OCD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment shows effects on brain chemistry that may relate to anti depressive effects This is a single treatment arm, open-label, Phase 2 study of ABX-002 in 30 adults with bipolar disorder and 5 healthy volunteers. Healthy volunteer participants will receive no drug treatment and will undergo 2 imaging sessions to confirm instrument and test - retest method reliability control. For bipolar disorder participants with depression, the study will include 3 study periods: 1. Screening Period of up to 4 weeks 2. 6-week Treatment Period 3. 2-week post dose Safety Follow-up Period. For healthy volunteers, the study will include 2 study periods: 1. Screening Period of up to 3 weeks 2. Imaging Period of up to 3 weeks.

Eligibility Criteria

This trial is for adults with bipolar disorder who are currently experiencing a depressive episode. It's also open to a small group of healthy volunteers for control purposes. Participants must be on stable medication regimens and able to comply with study procedures. Those with certain medical conditions or taking specific drugs that could interfere with the study are excluded.

Inclusion Criteria

For Health Volunteers: In good health, based on medical history, physical examination, vital sign measurements, and laboratory safety tests obtained at the Screening Visit

For Health Volunteers: 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

I have been diagnosed with bipolar disorder according to DSM-5 criteria.

Exclusion Criteria

For Bipolar Disorder Patients: Diagnosis of a personality disorder

I have a history of illness.

For Bipolar Disorder Patients: History of schizophrenia or schizoaffective disorder or a psychotic disorder unrelated to bipolar disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants with bipolar disorder receive ABX-002 adjunctively with their existing treatment for 6 weeks

6 weeks

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Imaging (Healthy Volunteers)

Healthy volunteers undergo imaging sessions to confirm instrument and test-retest method reliability

up to 3 weeks

2 imaging sessions

Treatment Details

Interventions

• ABX-002

Trial Overview The trial is testing ABX-002 as an add-on treatment for bipolar depression, assessing its impact on brain chemistry related to antidepressant effects. Bipolar participants will receive ABX-002 over six weeks, followed by two weeks of safety follow-up, while healthy controls undergo imaging sessions without drug treatment.

Participant Groups

Group I: ABX-002 + Mood Stabilizer (+/- antidepressant and/or single second-generation antipsychotic) Experimental Treatment 1 Intervention

Patients will continue to receive their mood stabilizer, antidepressant and/or single second-generation antipsychotic, that they were on at study entry, at a stable dose for the duration of the study in addition to ABX-002.

Group II: No Treatment + Imaging Sessions Active Control 1 Intervention

Healthy Volunteers will not receive any study treatment as their only assessment is 2 imaging sessions (baseline and retest)

Who Is Running the Clinical Trial?

Autobahn Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

310+