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Image of Autobahn Site #201 in Cromwell, United States.

ABX-002 for Bipolar Depression

Cromwell, CT

Phase 2

Recruiting

Research Sponsored by Autobahn Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Bipolar Disorder Patients: DSM-5-TR criteria for bipolar disorder based on Structured Clinical Interview for the DSM-5 - Clinical Trials Version (SCID-5-CT) at Screening

For Bipolar Disorder Patients: 17-item Hamilton Rating Scale for Depression total score ≥ 22 at Screening and Baseline

Must not have

For Bipolar Disorder Patients: Evident risk of suicide at Screening or Baseline

For Bipolar Disorder Patients: Received any course of deep brain stimulation in participant's lifetime or plans to receive deep brain stimulation during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2, 4, 6

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if adding ABX-002 to participants' current treatment can affect brain chemistry related to anti-depressive effects. The trial includes 30 adults with bipolar disorder and 5 healthy

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this summary does not provide details about side effects, it can be assumed that potential side effects may include those commonly associated with medications used in treating bipolar disorder such as nausea, weight changes, dizziness, mood swings or sleep disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My depression score is 22 or higher, indicating severe symptoms.

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I have been diagnosed with bipolar disorder for at least 2 years.

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I am experiencing a current depressive episode that has lasted no more than 24 months, without psychosis.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am at risk of suicide.

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I have had or plan to have deep brain stimulation for bipolar disorder.

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I have bipolar disorder with no uncontrolled serious health issues like cancer or heart disease.

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I am mentally capable and do not have significant emotional issues.

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I am currently taking high doses of anxiety or sleep medication for bipolar disorder.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 2, 4, 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 2, 4, 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 4, 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in the anterior cingulate cortex (ACC) nucleoside triphosphate/inorganic phosphate (NTP/Pi) concentration

Change from Baseline in the anterior cingulate cortex (ACC) phosphocreatine/inorganic (PCr/Pi) concentration

Methodological reliability control for 31P-MRS (Healthy Volunteer Only)

+1 more

Secondary study objectives

Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17)

Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)

Change from baseline for 6-item Hamilton Rating Scale for Depression (HAMD-6)

Other study objectives

Assessment of plasma pharmacokinetics (PK)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ABX-002 + Mood Stabilizer (+/- antidepressant and/or single second-generation antipsychotic)Experimental Treatment1 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 SessionsActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABX-002

2022

Completed Phase 1

~50

0 / 9Eligibility criteria met