NCT01034995: AGATE

An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder

Completed Phase 2 Last updated 13 April 2011

What this trial tests

Phase 2 trial testing SSR125543 in Major Depression in 580 participants. Completed in 1 March 2011.

Timeline

1 February 2010

Primary endpoint
1 March 2011

1 March 2011

Quick facts

Lead sponsor	Sanofi
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	580
Start date	1 February 2010
Primary completion	1 March 2011
Estimated completion	1 March 2011
Sites	73 locations across Belgium, Canada, Chile, Estonia, Finland, France, Germany, Netherlands

Drugs / interventions tested

• SSR125543 — full drug profile →
• escitalopram (escitalopram) — full drug profile →
• placebo

Conditions studied

• Major Depression — all drugs for Major Depression →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 64, any sex, with Major Depression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
  Time frame: 8 weeks

Sponsor's own description

Primary Objective:

* To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Objectives:

* To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
* To evaluate plasma concentrations of SSR125543

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Don't stress about CRF: assessing the translational failures of CRF<sub>1</sub>antagonists.
   Spierling SR, Zorrilla EP. · · 2017 · cited 131× · PMID 28265716 · DOI 10.1007/s00213-017-4556-2
2. Behavioral, biological, and chemical perspectives on targeting CRF(1) receptor antagonists to treat alcoholism.
   Zorrilla EP, Heilig M, de Wit H, Shaham Y. · · 2013 · cited 83× · PMID 23294766 · DOI 10.1016/j.drugalcdep.2012.12.017
3. Sex differences in the hypothalamic-pituitary-adrenal axis: An obstacle to antidepressant drug development?
   Kokras N, Hodes GE, Bangasser DA, Dalla C. · · 2019 · cited 77× · PMID 31093959 · DOI 10.1111/bph.14710
4. Sex differences in corticotropin-releasing factor receptor-1 action within the dorsal raphe nucleus in stress responsivity.
   Howerton AR, Roland AV, Fluharty JM, Marshall A, et al · · 2014 · cited 64× · PMID 24289884 · DOI 10.1016/j.biopsych.2013.10.013
5. Update on corticotropin-releasing factor pharmacotherapy for psychiatric disorders: a revisionist view.
   Koob GF, Zorrilla EP. · · 2012 · cited 39× · PMID 22157874 · DOI 10.1038/npp.2011.213
6. CRF-R1 Antagonist Treatment Exacerbates Circadian Corticosterone Secretion under Chronic Stress, but Preserves HPA Feedback Sensitivity.
   Ibarguen-Vargas Y, Leman S, Palme R, Belzung C, et al · · 2021 · cited 7× · PMID 34959395 · DOI 10.3390/pharmaceutics13122114