ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment

Browse trials for

• Depressive Disorder 4,845
• Depression 8,057
• Depressive Disorder, Major 2,741

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 357 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Placebo comparator
  Placebo

  Drug: Placebo

• Experimental
  RO4995819 15 mg

  Drug: RO4995819

• Experimental
  RO4995819 30 mg

  Drug: RO4995819

• Experimental
  RO4995819 5 mg

  Drug: RO4995819

Interventions

• DrugPlacebo

  matching placebo to RO4995819 oral once daily for 6 weeks

• DrugRO4995819

  5 mg oral once daily for 6 weeks

• DrugRO4995819

  15 mg oral once daily for 6 weeks

• DrugRO4995819

  30 mg oral once daily for 6 weeks

Primary outcomes

1. Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores

   Time frame: 6 weeks

Secondary outcomes

1. Safety (incidence of a adverse events)

   Time frame: 6 weeks

2. Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)

   Time frame: 6 weeks

3. Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score)

   Time frame: 6 weeks

Publications

• Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3. PubMed 34510411 ↗
• Umbricht D, Niggli M, Sanwald-Ducray P, Deptula D, Moore R, Grunbauer W, Boak L, Fontoura P. Randomized, Double-Blind, Placebo-Controlled Trial of the mGlu2/3 Negative Allosteric Modulator Decoglurant in Partially Refractory Major Depressive Disorder. J Clin Psychiatry. 2020 Jul 14;81(4):18m12470. doi: 10.4088/JCP.18m12470. PubMed 32663909 ↗