Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
Status:
RECRUITING
Trial end date:
2026-03-13
Target enrollment:
Participant gender:
Summary
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.