NCT00514865

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

Completed Phase 2 Last updated 26 November 2023

What this trial tests

Phase 2 trial testing ONO-2333Ms Experimental 2 in Major Depressive Disorder in 278 participants. Completed in 1 June 2008.

Timeline

13 June 2007

Primary endpoint
1 April 2008

1 June 2008

Quick facts

Lead sponsor	Ono Pharma USA Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	278
Start date	13 June 2007
Primary completion	1 April 2008
Estimated completion	1 June 2008
Sites	1 location across United States

Drugs / interventions tested

• ONO-2333Ms Experimental 2 — full drug profile →
• Placebo
• ONO-2333Ms Experimental 1 — full drug profile →

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Ono Pharma USA Inc — full company profile →

Who can join

Adults 18 to 55, any sex, with Major Depressive Disorder. 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 to treatment endpoint in the MADRS total score
  Time frame: 8 weeks

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder

Publications & conference data

7 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. Progress in corticotropin-releasing factor-1 antagonist development.
   Zorrilla EP, Koob GF. · · 2010 · cited 131× · PMID 20206287 · DOI 10.1016/j.drudis.2010.02.011
3. Neurobiological mechanisms of addiction: focus on corticotropin-releasing factor.
   Koob GF, Zorrilla EP. · · 2010 · cited 95× · PMID 20047160
4. 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
5. 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
6. 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
7. 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