Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)

NCT06633016 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ABX-002-2001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 50

Brief Summary

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. 1.Screening, approximately 35 days
2. 2.42-day Treatment Period
3. 3.2-week post dose Safety Follow-up Period
4. 4.6-month postdose targeted safety follow-up period

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17)

  The HAMD-17 is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.

  6 weeks

Secondary Outcomes (6)

• Change from Baseline for Clinical Global Impression of Severity (CGI-S)

  6 weeks

• Change from Baseline for Sheehan Disability Scale (SDS)

  6 weeks

• Change from baseline for 6-item Hamilton Rating Scale for Depression (HAMD-6)

  6 weeks

• Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)

  6 weeks

• Patient Global Impression-Improvement (PGI-I)

  6 weeks

Study Arms (2)

ABX-002 + SSRI/SNRI

EXPERIMENTAL

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.

Drug: ABX-002

Placebo + SSRI/SNRI

PLACEBO COMPARATOR

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 the Placebo.

Other: Placebo

Interventions

ABX-002 DRUG

ABX-002 oral solution in 1-mL cyclic olefin polymer prefilled syringes, taken on an empty stomach first thing in the morning followed by 240 mL (8 oz) of water.

ABX-002 + SSRI/SNRI

Placebo OTHER

Comparator Placebo oral solution in 1-mL cyclic olefin polymer prefilled syringes, taken on an empty stomach first thing in the morning followed by 240 mL (8 oz) of water.

Placebo + SSRI/SNRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the DSM-5 criteria for Major Depressive Disorder, with a current major depressive episode duration of \> 6 weeks and ≤ 18 months.
• A score of ≤ 22 (midrange mild/moderate) on the Hamilton Anxiety Rating Scale.
• Montgomery-Asberg Depression Rating Scale total score of \> 24 \[indicating moderate to severe depression\] at Screening and at Baseline.
• Subject is compliantly using a single selective serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor antidepressant for at least 6 weeks for their current episode of depression, with an adequate dose, and with an inadequate response as defined by the Antidepressant Treatment Response Questionnaire. The dosage of the current antidepressant must have been stable for the past 4 weeks, and the dosage and specific antidepressant used should remain the same from Screening through the end of the Follow-up Period.

You may not qualify if:

• Note: History implies lifetime history, unless otherwise specified
• 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.
• Current diagnosis or active symptoms within the last 2 years of obsessive-compulsive disorder, posttraumatic stress disorder, panic disorder, or eating disorder, according to DSM-5 criteria.
• Has failed more than 2 single selective serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor antidepressant treatments, including the current serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor, during the current depressive episode, despite an adequate dose (per Antidepressant Treatment Response Questionnaire) and duration (at least 6 weeks).
• Failure to respond to triiodothyronine or thyroxine augmentation for the treatment of depression.
• Started new psychotherapy or had a change in the intensity of psychotherapy within 8 weeks before Screening.
• Is suicidal at Screening or Baseline
• History or current evidence within previous 3 months before Screening of uncontrolled, clinically significant neurological, gastrointestinal, respiratory, renal, hepatic, immunological, hematological, or other medical disorder, including cancer, that would jeopardize the safe participation of the subject in the study (in the opinion of the Investigator).
• History of thyroid disease
• History of multiple endocrine neoplasia syndrome
• Diagnosis of epilepsy or history of convulsions, including childhood febrile seizure. Use of co-administered drugs that may lower seizure threshold is excluded.
• Females who are pregnant, intend to become pregnant or are breastfeeding.
• Antidepressants: Prior use of psychedelics, ketamine, or esketamine, for the treatment of Major Depressive Disorder.
• Antidepressants: Current use, or use within 4 weeks prior to Screening, of any other augmentation agents for Major Depressive Disorder (e.g. second-generation antipsychotics \[SGA\], monoamine oxidase inhibitors \[MAOI\], tricyclic antidepressants \[TCA\], lithium, or bupropion)
• Current or prior use of treatment for hypothyroidism including but not limited to synthetic or natural thyroid hormone, triiodothyronine and/or thyroxine.

Sponsors & Collaborators

• Autobahn Therapeutics, Inc.: lead

Study Sites (50)

Autobahn Site #131

Birmingham, Alabama, 35294, United States

RECRUITING

Autobahn Site #132

Chandler, Arizona, 85224, United States

ACTIVE NOT RECRUITING

Autobahn Site #116

Phoenix, Arizona, 85102, United States

ACTIVE NOT RECRUITING

Autobahn Site #136

Tucson, Arizona, 85704, United States

WITHDRAWN

Autobahn Site #150

Anaheim, California, 92805, United States

RECRUITING

Autobahn Site #113

Encino, California, 91316, United States

WITHDRAWN

Autobahn Site #133

Encino, California, 91316, United States

WITHDRAWN

Autobahn Site #124

Glendale, California, 91206, United States

RECRUITING

Autobahn Site #140

Long Beach, California, 90807, United States

RECRUITING

Autobahn Site #121

Los Alamitos, California, 90720, United States

WITHDRAWN

Autobahn Site #117

Newport Beach, California, 92660, United States

WITHDRAWN

Autobahn Site #106

Oceanside, California, 92056, United States

ACTIVE NOT RECRUITING

Autobahn Site #152

Orange, California, 92866, United States

RECRUITING

Autobahn Site #151

Rancho Cucamonga, California, 91730, United States

RECRUITING

Autobahn Site #119

San Jose, California, 95124, United States

RECRUITING

Autobahn Site #126

Walnut Creek, California, 94596, United States

RECRUITING

Autobahn Site #149

West Covina, California, 91790, United States

RECRUITING

Autobahn Site #122

Cromwell, Connecticut, 06416, United States

RECRUITING

Autobahn Site #108

Brandon, Florida, 33511, United States

RECRUITING

Autobahn Site #110

Hialeah, Florida, 33012, United States

RECRUITING

Autobahn Site #101

Jacksonville, Florida, 32256, United States

RECRUITING

Autobahn Site #139

Lake City, Florida, 32055, United States

ACTIVE NOT RECRUITING

Autobahn Site #111

Miami, Florida, 33144, United States

RECRUITING

Autobahn Site #141

Miami, Florida, 33157, United States

ACTIVE NOT RECRUITING

Autobahn Site #147

Miami Gardens, Florida, 33014, United States

RECRUITING

Autobahn Site #102

Orlando, Florida, 32822, United States

ACTIVE NOT RECRUITING

Autobahn Site #148

Tampa, Florida, 33629, United States

RECRUITING

Autobahn Site #123

Atlanta, Georgia, 30328, United States

ACTIVE NOT RECRUITING

Autobahn Site #112

Decatur, Georgia, 30030, United States

RECRUITING

Autobahn Site #142

Peachtree Corners, Georgia, 30071, United States

RECRUITING

Autobahn Site #120

Savannah, Georgia, 31405, United States

ACTIVE NOT RECRUITING

Autobahn Site #154

Elgin, Illinois, 60123, United States

ACTIVE NOT RECRUITING

Autobahn Site #137

Boston, Massachusetts, 02130, United States

RECRUITING

Autobahn Site #138

Watertown, Massachusetts, 02472, United States

ACTIVE NOT RECRUITING

Autobahn Site #127

Saint Charles, Missouri, 63304, United States

RECRUITING

Autobahn Site #130

Las Vegas, Nevada, 89121, United States

WITHDRAWN

Autobahn Site #129

Berlin, New Jersey, 08009, United States

RECRUITING

Autobahn Site #105

Brooklyn, New York, 11229, United States

RECRUITING

Autobahn Site #134

Brooklyn, New York, 11235, United States

RECRUITING

Autobahn Site #125

New York, New York, 10022, United States

ACTIVE NOT RECRUITING

Autobahn Site #104

Staten Island, New York, 10314, United States

RECRUITING

Autobahn Site #109

Beachwood, Ohio, 44122, United States

RECRUITING

Autobahn Site #107

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Autobahn Site #128

North Charleston, South Carolina, 29405, United States

ACTIVE NOT RECRUITING

Autobahn Site #153

Beaumont, Texas, 77701, United States

RECRUITING

Autobahn Site #146

San Antonio, Texas, 78215, United States

RECRUITING

Autobahn Site #144

Sherman, Texas, 75092, United States

RECRUITING

Autobahn Site #159

Orem, Utah, 84058, United States

RECRUITING

Autobahn Site #145

Fairfax, Virginia, 22030, United States

RECRUITING

Autobahn Site #143

Bellevue, Washington, 98007, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Ashlee Heldreth, MS

CONTACT

8582573418; clinicaltrials@autobahntx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study participants, Investigator, and study site staff, Sponsor will be blinded to treatment assignments (ABX-002 or placebo solution).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 9, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (50)