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ABX-002 for Depression

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

Meets the DSM-5 criteria for Major Depressive Disorder, with a current major depressive episode duration being no longer than 12 months

Montgomery-Asberg Depression Rating Scale total score indicating moderate to severe depression at Screening and at Baseline

Must not have

History of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features or concomitant DSM-5 depressive disorders, bipolar I or II disorder, cyclothymic disorder, delirium, dementia, amnestic disorder, or cognitive disorder

Diagnosis of epilepsy or history of convulsions, including childhood febrile seizure. Use of co-administered drugs that may lower seizure threshold is excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial aims to see if adding ABX-002 to an existing antidepressant can help improve depression symptoms in adults with moderate to severe major depressive disorder who haven't responded well to their current antidepressant

Who is the study for?

Adults with moderate to severe major depressive disorder who haven't had enough improvement from their current antidepressant can join this study. They must pass a screening and be okay with being randomly assigned to receive either ABX-002 or a placebo.

What is being tested?

The AMPLIFY trial is testing if adding ABX-002 to standard antidepressants helps improve symptoms in those not responding well to treatment. Participants will be blindly given either ABX-002 or a fake drug (placebo) for comparison over six weeks, followed by safety checks.

What are the potential side effects?

Possible side effects of ABX-002 are not detailed here but may include typical reactions seen with psychiatric medications such as headaches, nausea, sleep issues, and potential mood changes.

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 Major Depressive Disorder and my current episode has lasted no more than 12 months.

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My depression is moderate to severe according to a specific test.

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I've been on the same antidepressant for 6 weeks to 12 months without feeling better.

Exclusion Criteria

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

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I have not been diagnosed with major psychiatric or cognitive disorders.

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I have epilepsy or a history of seizures, and I'm not taking drugs that could increase my risk of seizures.

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I have not taken biotin for 7 days before starting the study and won't until it ends.

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I am not taking strong medications that affect liver enzymes.

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I am not pregnant, do not plan to become pregnant soon, and am not breastfeeding.

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I have tried more than 2 antidepressants without success for my current depressive episode.

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I have used psychedelics, ketamine, or esketamine for depression before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks 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 17-item Hamilton Rating Scale for Depression (HAMD-17)

Secondary study objectives

Assessment of safety and tolerability of ABX-002 compared with placebo using adverse events

Assessment of safety and tolerability of ABX-002 compared with placebo using physical evaluations

Assessment of safety and tolerability of ABX-002 compared with placebo using standard laboratory safety tests

+7 more

Other study objectives

To evaluate plasma pharmacokinetics of ABX-002

To evaluate the effects of ABX-002 on pharmacodynamic biomarker, brain-derived neurotropic factor

To evaluate the effects of ABX-002 on pharmacodynamic biomarker, c-reactive protein

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ABX-002 + SSRI/SNRIExperimental Treatment1 Intervention

Patients continue to receive their selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study in addition to ABX-002.

Group II: Placebo + SSRI/SNRIPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABX-002

2022

Completed Phase 1

~50

0 / 10Eligibility criteria met