A Study to Assess the Change in Disease Activity and Adverse Events of AGN-151607-DP for the Treatment of Major Depressive Disorder in Adult Participants
Key facts
- Where
- Bad Homburg, Erbach, Hamburg és Hanover, NémetországSee the 4 sites
- Phase
- 2. fázis
Where in Németország
- Zentrum fuer klinische Forschung Dr. I. Schoell GmbHBad Homburg, NémetországToborzás még nem indult
- Neuro Centrum Science GmbHErbach, NémetországToborzás még nem indult
- Asklepios Kliniken Hamburg GmbHHamburg, NémetországToborzás még nem indult
- The Fraunhofer Institute For Toxicology And Experimental Medicine ITEMHanover, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie Deutschland GmbH & Co. KG
- Trial code
- EU 2025-525047-40-00
- Record updated
- 2026. november 11.
- Original description
Evaluate the antidepressant efficacy of AGN-151607-DP as a monotherapy compared to placebo in participants with MDD.Read full original descriptionShow less
A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study with an Open-Label Treatment Period to Evaluate the Efficacy and Safety of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Treatment of Major Depressive Disorder
Evaluate the antidepressant efficacy of AGN-151607-DP as a monotherapy compared to placebo in participants with MDD.
Inclusion: Male and female subjects from 18 to 70 years of age, inclusive, at the time of informed consent; Have at least 1 prior episode meeting the DSM-5-TR criteria for MDD; Subject has a BMI of ≥ 18 to ≤ 45; Current major depressive episode meets the following criteria: HAM-D17 total score ≥ 22, CGI-S-MDD score ≥ 4, and episode duration of ≥ 4 weeks, but no more than 24 months.
Exclusion: Concurrent antidepressant medication(s) or herbal/homeopathic remedies targeting signs and symptoms of depression within 2 weeks or 5 half-lives, whichever is longer; Lifetime history of meeting DSM-5-TR criteria for: -- Schizophrenia spectrum or other psychotic disorder -- Bipolar disorder -- Major neurocognitive disorder -- Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the subject's ability to consent, follow study directions, or otherwise safely participate in the study -- Dissociative disorder -- Post-traumatic stress disorder; Participants have treatment resistance in the current episode (defined as an inadequate response with < 50% improvement of depressive symptoms to 2 or more antidepressant treatments of adequate.