Actively Recruiting
Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
Led by Autobahn Therapeutics, Inc. · Updated on 2026-01-20
230
Participants Needed
50
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period 4. 6-month postdose targeted safety follow-up period
CONDITIONS
Official Title
Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Meets DSM-5 criteria for Major Depressive Disorder with a current episode lasting more than 6 weeks and up to 18 months
- Hamilton Anxiety Rating Scale score of 22 or less
- Montgomery-Asberg Depression Rating Scale score greater than 24 at screening and baseline
- Taking a single SSRI or SNRI antidepressant at an adequate dose for at least 6 weeks with inadequate response
- Stable antidepressant dose for at least 4 weeks prior to screening and throughout the study
You will not qualify if you...
- History of schizophrenia, psychotic disorders, major depressive disorder with psychotic features, bipolar I or II disorder, cyclothymic disorder, delirium, dementia, amnestic or cognitive disorders
- Current or recent (within 2 years) diagnosis of obsessive-compulsive disorder, PTSD, panic disorder, or eating disorders
- Primary diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
- Current or recent (within 2 years) self-injurious behavior
- Failure of more than 2 SSRI/SNRI antidepressant treatments during current episode
- Failure to respond to thyroid hormone augmentation for depression
- New or changed psychotherapy within 8 weeks prior to screening
- Suicidal at screening or baseline
- Uncontrolled significant medical disorders within 3 months prior to screening
- History of thyroid disease or multiple endocrine neoplasia syndrome
- Diagnosis of epilepsy or history of convulsions
- Pregnant, planning pregnancy, or breastfeeding
- Prior use of psychedelics, ketamine, or esketamine for depression
- Recent use (within 4 weeks) of other augmentation agents for depression
- Current or prior treatment for hypothyroidism
- Use of biotin within 14 days prior to Day 1 through last visit
- Use of strong cytochrome P450 3A4 inhibitors or inducers
- Substance abuse or illicit drug use within 1 year prior to screening
- History or presence of cataracts, glaucoma, inflammatory eye disease, or prior eye surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 locations
1
Autobahn Site #131
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Autobahn Site #132
Chandler, Arizona, United States, 85224
Active, Not Recruiting
3
Autobahn Site #116
Phoenix, Arizona, United States, 85102
Active, Not Recruiting
4
Autobahn Site #136
Tucson, Arizona, United States, 85704
Withdrawn
5
Autobahn Site #150
Anaheim, California, United States, 92805
Actively Recruiting
6
Autobahn Site #113
Encino, California, United States, 91316
Withdrawn
7
Autobahn Site #133
Encino, California, United States, 91316
Withdrawn
8
Autobahn Site #124
Glendale, California, United States, 91206
Actively Recruiting
9
Autobahn Site #140
Long Beach, California, United States, 90807
Actively Recruiting
10
Autobahn Site #121
Los Alamitos, California, United States, 90720
Withdrawn
11
Autobahn Site #117
Newport Beach, California, United States, 92660
Withdrawn
12
Autobahn Site #106
Oceanside, California, United States, 92056
Active, Not Recruiting
13
Autobahn Site #152
Orange, California, United States, 92866
Actively Recruiting
14
Autobahn Site #151
Rancho Cucamonga, California, United States, 91730
Actively Recruiting
15
Autobahn Site #119
San Jose, California, United States, 95124
Actively Recruiting
16
Autobahn Site #126
Walnut Creek, California, United States, 94596
Actively Recruiting
17
Autobahn Site #149
West Covina, California, United States, 91790
Actively Recruiting
18
Autobahn Site #122
Cromwell, Connecticut, United States, 06416
Actively Recruiting
19
Autobahn Site #108
Brandon, Florida, United States, 33511
Actively Recruiting
20
Autobahn Site #110
Hialeah, Florida, United States, 33012
Actively Recruiting
21
Autobahn Site #101
Jacksonville, Florida, United States, 32256
Actively Recruiting
22
Autobahn Site #139
Lake City, Florida, United States, 32055
Active, Not Recruiting
23
Autobahn Site #111
Miami, Florida, United States, 33144
Actively Recruiting
24
Autobahn Site #141
Miami, Florida, United States, 33157
Active, Not Recruiting
25
Autobahn Site #147
Miami Gardens, Florida, United States, 33014
Actively Recruiting
26
Autobahn Site #102
Orlando, Florida, United States, 32822
Active, Not Recruiting
27
Autobahn Site #148
Tampa, Florida, United States, 33629
Actively Recruiting
28
Autobahn Site #123
Atlanta, Georgia, United States, 30328
Active, Not Recruiting
29
Autobahn Site #112
Decatur, Georgia, United States, 30030
Actively Recruiting
30
Autobahn Site #142
Peachtree Corners, Georgia, United States, 30071
Actively Recruiting
31
Autobahn Site #120
Savannah, Georgia, United States, 31405
Active, Not Recruiting
32
Autobahn Site #154
Elgin, Illinois, United States, 60123
Active, Not Recruiting
33
Autobahn Site #137
Boston, Massachusetts, United States, 02130
Actively Recruiting
34
Autobahn Site #138
Watertown, Massachusetts, United States, 02472
Active, Not Recruiting
35
Autobahn Site #127
Saint Charles, Missouri, United States, 63304
Actively Recruiting
36
Autobahn Site #130
Las Vegas, Nevada, United States, 89121
Withdrawn
37
Autobahn Site #129
Berlin, New Jersey, United States, 08009
Actively Recruiting
38
Autobahn Site #105
Brooklyn, New York, United States, 11229
Actively Recruiting
39
Autobahn Site #134
Brooklyn, New York, United States, 11235
Actively Recruiting
40
Autobahn Site #125
New York, New York, United States, 10022
Active, Not Recruiting
41
Autobahn Site #104
Staten Island, New York, United States, 10314
Actively Recruiting
42
Autobahn Site #109
Beachwood, Ohio, United States, 44122
Actively Recruiting
43
Autobahn Site #107
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
44
Autobahn Site #128
North Charleston, South Carolina, United States, 29405
Active, Not Recruiting
45
Autobahn Site #153
Beaumont, Texas, United States, 77701
Actively Recruiting
46
Autobahn Site #146
San Antonio, Texas, United States, 78215
Actively Recruiting
47
Autobahn Site #144
Sherman, Texas, United States, 75092
Actively Recruiting
48
Autobahn Site #159
Orem, Utah, United States, 84058
Actively Recruiting
49
Autobahn Site #145
Fairfax, Virginia, United States, 22030
Actively Recruiting
50
Autobahn Site #143
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
A
Ashlee Heldreth, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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