RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. For bipolar disorder participants who are experiencing an episode of 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.

Official Title

A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 on Brain Bioenergetics in Adults With Bipolar Disorder Experiencing an Episode of Depression

Quick Facts

Study Start:2025-03-28
Study Completion:2026-03-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06869187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Regina Griffin, MS
CONTACT
8582573418
clinicaltrials@autobahntx.com

Study Locations (Sites)

Autobahn Site #201
Cromwell, Connecticut, 06416
United States
Autobahn Site #208
Cherry Hill, New Jersey, 08002
United States
Autobahn Site #205
Marlton, New Jersey, 08053
United States
Autobahn Site #203
Brooklyn, New York, 11235
United States
Autobahn Site #202
New York, New York, 10022
United States
Autobahn Site #204
Staten Island, New York, 10314
United States

Collaborators and Investigators

Sponsor: Autobahn Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-28
Study Completion Date2026-03-13

Study Record Updates

Study Start Date2025-03-28
Study Completion Date2026-03-13

Terms related to this study

Additional Relevant MeSH Terms

  • Bipolar Disorder Depression