RECRUITING

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

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 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

Official Title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder

Quick Facts

Study Start:2024-09-20
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06633016

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets the DSM-5 criteria for Major Depressive Disorder, with a current major depressive episode duration of \> 6 weeks and ≤ 18 months.
  2. * A score of ≤ 22 (midrange mild/moderate) on the Hamilton Anxiety Rating Scale.
  3. * Montgomery-Asberg Depression Rating Scale total score of \> 24 \[indicating moderate to severe depression\] at Screening and at Baseline.
  4. * 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.
  1. * 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.
  2. * 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.
  3. * Primary diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder, according to DSM-5 criteria. Current or history within the last 2 years of self-injurious behavior is exclusionary.
  4. * 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).
  5. * Failure to respond to triiodothyronine or thyroxine augmentation for the treatment of depression.
  6. * Started new psychotherapy or had a change in the intensity of psychotherapy within 8 weeks before Screening.
  7. * Is suicidal at Screening or Baseline
  8. * 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).
  9. * History of thyroid disease
  10. * History of multiple endocrine neoplasia syndrome
  11. * Diagnosis of epilepsy or history of convulsions, including childhood febrile seizure. Use of co-administered drugs that may lower seizure threshold is excluded.
  12. * Females who are pregnant, intend to become pregnant or are breastfeeding.
  13. * Antidepressants: Prior use of psychedelics, ketamine, or esketamine, for the treatment of Major Depressive Disorder.
  14. * 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)
  15. * Current or prior use of treatment for hypothyroidism including but not limited to synthetic or natural thyroid hormone, triiodothyronine and/or thyroxine.
  16. * Concomitant use of biotin of any dose and in any preparation 14 days prior to Day 1 until after the last study visit at Week 8 (Day 56).
  17. * Medications that are strong cytochrome P450 3A4 inhibitors or strong cytochrome P450 3A4 inducers are not allowed.
  18. * Prescription drug/controlled substance abuse, or illicit substance use within 1 year of Screening or positive urine drug results at Screening or Baseline for an illicit substance.
  19. * History or presence of cataract on ophthalmic examination (including slit-lamp), glaucoma, inflammatory eye disease or prior ophthalmic surgical procedures or laser surgery in either eye

Contacts and Locations

Study Contact

Ashlee Heldreth, MS
CONTACT
8582573418
clinicaltrials@autobahntx.com

Study Locations (Sites)

Autobahn Site #131
Birmingham, Alabama, 35294
United States
Autobahn Site #132
Chandler, Arizona, 85224
United States
Autobahn Site #116
Phoenix, Arizona, 85102
United States
Autobahn Site #136
Tucson, Arizona, 85704
United States
Autobahn Site #150
Anaheim, California, 92805
United States
Autobahn Site #113
Encino, California, 91316
United States
Autobahn Site #133
Encino, California, 91316
United States
Autobahn Site #124
Glendale, California, 91206
United States
Autobahn Site #140
Long Beach, California, 90807
United States
Autobahn Site #121
Los Alamitos, California, 90720
United States
Autobahn Site #117
Newport Beach, California, 92660
United States
Autobahn Site #106
Oceanside, California, 92056
United States
Autobahn Site #152
Orange, California, 92866
United States
Autobahn Site #151
Rancho Cucamonga, California, 91730
United States
Autobahn Site #119
San Jose, California, 95124
United States
Autobahn Site #126
Walnut Creek, California, 94596
United States
Autobahn Site #149
West Covina, California, 91790
United States
Autobahn Site #122
Cromwell, Connecticut, 06416
United States
Autobahn Site #108
Brandon, Florida, 33511
United States
Autobahn Site #110
Hialeah, Florida, 33012
United States
Autobahn Site #101
Jacksonville, Florida, 32256
United States
Autobahn Site #139
Lake City, Florida, 32055
United States
Autobahn Site #111
Miami, Florida, 33144
United States
Autobahn Site #141
Miami, Florida, 33157
United States
Autobahn Site #147
Miami Gardens, Florida, 33014
United States
Autobahn Site #102
Orlando, Florida, 32822
United States
Autobahn Site #148
Tampa, Florida, 33629
United States
Autobahn Site #123
Atlanta, Georgia, 30328
United States
Autobahn Site #112
Decatur, Georgia, 30030
United States
Autobahn Site #142
Peachtree Corners, Georgia, 30071
United States
Autobahn Site #120
Savannah, Georgia, 31405
United States
Autobahn Site #154
Elgin, Illinois, 60123
United States
Autobahn Site #137
Boston, Massachusetts, 02130
United States
Autobahn Site #138
Watertown, Massachusetts, 02472
United States
Autobahn Site #127
Saint Charles, Missouri, 63304
United States
Autobahn Site #130
Las Vegas, Nevada, 89121
United States
Autobahn Site #129
Berlin, New Jersey, 08009
United States
Autobahn Site #105
Brooklyn, New York, 11229
United States
Autobahn Site #134
Brooklyn, New York, 11235
United States
Autobahn Site #125
New York, New York, 10022
United States
Autobahn Site #104
Staten Island, New York, 10314
United States
Autobahn Site #109
Beachwood, Ohio, 44122
United States
Autobahn Site #107
Oklahoma City, Oklahoma, 73112
United States
Autobahn Site #128
North Charleston, South Carolina, 29405
United States
Autobahn Site #153
Beaumont, Texas, 77701
United States
Autobahn Site #146
San Antonio, Texas, 78215
United States
Autobahn Site #144
Sherman, Texas, 75092
United States
Autobahn Site #159
Orem, Utah, 84058
United States
Autobahn Site #145
Fairfax, Virginia, 22030
United States
Autobahn Site #143
Bellevue, Washington, 98007
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 Date2024-09-20
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-09-20
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder