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NCT06869187RECRUITINGIRB Ready

Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults

Sponsored by Autobahn Therapeutics, Inc.

Quick Self-Assessment

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๐Ÿ“Š
1 of 35 participants interested
3% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment(s) shows 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 30 adults with bipolar depression. 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.

Who Can Participate

Inclusion Criteria

(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 โ‰ฅ 6 weeks and โ‰ค 24 months
17-item Hamilton Rating Scale for Depression total score โ‰ฅ 22 at Screening and Baseline
Young Mania Rating Scale total score โ‰ค 12 at Screening and Baseline
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 a

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

35 participants

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Age Range

18 Years - 65 Years

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Gender

ALL

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Sponsor

Autobahn Therapeutics, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Walnut Creek

California

Location available
View Walnut Creek location page
RECRUITING

Cromwell

Connecticut

Location available
View Cromwell location page
NOT_YET_RECRUITING

Hartford

Connecticut

Location available
View Hartford location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Cherry Hill

New Jersey

Location available
View Cherry Hill location page
RECRUITING

Hamilton

New Jersey

Location available
View Hamilton location page
RECRUITING

Marlton

New Jersey

Location available
View Marlton location page
RECRUITING

Brooklyn

New York

Location available
View Brooklyn location page
NOT_YET_RECRUITING

New York

New York

Location available
View New York location page

๐Ÿ“ And 2 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Bipolar Depression Treatment in Cromwell?

Join others in Connecticut exploring innovative treatment options through clinical research

Bipolar Depression Treatment Options in Cromwell, Connecticut

If you're searching for Bipolar Depression treatment in Cromwell, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Cromwell, Cherry Hill, Marlton and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Bipolar Depression. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Connecticut
Now Enrolling
Up to 35 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bipolar Depression?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Bipolar Depression

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Bipolar Depression Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06869187. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.