Under construction – not a live service
Sign in
Not yet taking people in GermanyPhase 2

Testing AGN-151607-DP against placebo for major depressive disorder in adults

Tests AGN-151607-DP alone against placebo in adults with major depressive disorder.

Key facts

Who runs it
AbbVie Deutschland GmbH & Co. KG
Where
Bad Homburg, Erbach, Hamburg, and Hanover, GermanySee the 4 sites
Registry title
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
Status
Not yet recruiting
Phase
Phase 2
People taking part
40 people, planned
Starts
30 Nov 2026
Expected to end
30 Mar 2029
Type of study
Interventional
Record updated
11 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a current episode of major depression who have had at least 1 earlier episode.

Age
18 to 70 years old.
Sex
Men and women can join.
Disease stage
Current depressive episode lasting from 4 weeks up to 24 months, with HAM-D17 total score of 22 or more and CGI-S-MDD score of 4 or more.
Earlier treatment
People cannot join if the current episode did not respond to 2 or more antidepressant treatments. No antidepressant or herbal remedy for depression within 2 weeks or 5 half-lives, whichever is longer.

Main reasons for not taking part

  • No response (less than 50% improvement) to 2 or more antidepressant treatments in the current episode
  • Taking antidepressants or herbal/homeopathic remedies for depression within 2 weeks or 5 half-lives, whichever is longer
  • Ever had schizophrenia or another psychotic disorder, or bipolar disorder
  • Ever had a major neurocognitive disorder, a dissociative disorder or post-traumatic stress disorder
  • Neurodevelopmental disorder that is more than mild or that affects the ability to consent or take part safely

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Germany

  • Zentrum fuer klinische Forschung Dr. I. Schoell GmbHBad Homburg, GermanyNot yet recruiting
  • Neuro Centrum Science GmbHErbach, GermanyNot yet recruiting
  • Asklepios Kliniken Hamburg GmbHHamburg, GermanyNot yet recruiting
  • The Fraunhofer Institute For Toxicology And Experimental Medicine ITEMHanover, GermanyNot yet recruiting

About the trial

What the trial wants to find out

Evaluate the antidepressant efficacy of AGN-151607-DP as a monotherapy compared to placebo in participants with MDD.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Testing AGN-151607-DP against placebo for major depressive disorder in adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 November 2026