drugset / Trial / NCT05017311
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
Phase 4
Recruiting
400 enrolled
Nova Scotia Health Authority
Centre for Addiction and Mental Health · collabDalhousie University · collabMcGill University · collabMcMaster University · collabOntario Shores Centre for Mental Health Sciences · collabQueen's University · collabSimon Fraser University · collabUnity Health Toronto · collabUniversity of British Columbia · collabUniversity of Calgary · collabUniversity of Michigan · collabUniversity of Ottawa · collabUniversity of Saskatchewan · collab
RandomizedFactorialDouble-blindTreatment
Summary
This is a study that will test a predictive biomarker algorithm based on results from a previous study. The goal of this study is to integrate clinical, imaging, EEG, and molecular data across 8 sites to predict treatment outcome for patients experiencing a major depressive episode (MDE).
Timeline
- Start
- 2023-01-20
- Primary completion
- 2028-12-31
- Completion
- 2029-04-30
Publications
- Background Lam RW, Milev R, Rotzinger S, Andreazza AC, Blier P, Brenner C, Daskalakis ZJ, Dharsee M, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Geraci J, Giacobbe P, Feilotter HE, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, Liotti M, MacQueen GM, McAndrews MP, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Salomons TV, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Kennedy SH; CAN-BIND Investigator Team. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort. BMC Psychiatry. 2016 Apr 16;16:105. doi: 10.1186/s12888-016-0785-x.
- Background Kennedy SH, Lam RW, Rotzinger S, Milev RV, Blier P, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Giacobbe P, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, McInerney S, MacQueen GM, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Sassi RB, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Yu J, Uher R; CAN-BIND Investigator Team. Symptomatic and Functional Outcomes and Early Prediction of Response to Escitalopram Monotherapy and Sequential Adjunctive Aripiprazole Therapy in Patients With Major Depressive Disorder: A CAN-BIND-1 Report. J Clin Psychiatry. 2019 Feb 5;80(2):18m12202. doi: 10.4088/JCP.18m12202.
- Background Farzan F, Atluri S, Frehlich M, Dhami P, Kleffner K, Price R, Lam RW, Frey BN, Milev R, Ravindran A, McAndrews MP, Wong W, Blumberger D, Daskalakis ZJ, Vila-Rodriguez F, Alonso E, Brenner CA, Liotti M, Dharsee M, Arnott SR, Evans KR, Rotzinger S, Kennedy SH. Standardization of electroencephalography for multi-site, multi-platform and multi-investigator studies: insights from the canadian biomarker integration network in depression. Sci Rep. 2017 Aug 7;7(1):7473. doi: 10.1038/s41598-017-07613-x.
- Background Lopez JP, Fiori LM, Cruceanu C, Lin R, Labonte B, Cates HM, Heller EA, Vialou V, Ku SM, Gerald C, Han MH, Foster J, Frey BN, Soares CN, Muller DJ, Farzan F, Leri F, MacQueen GM, Feilotter H, Tyryshkin K, Evans KR, Giacobbe P, Blier P, Lam RW, Milev R, Parikh SV, Rotzinger S, Strother SC, Lewis CM, Aitchison KJ, Wittenberg GM, Mechawar N, Nestler EJ, Uher R, Kennedy SH, Turecki G. MicroRNAs 146a/b-5 and 425-3p and 24-3p are markers of antidepressant response and regulate MAPK/Wnt-system genes. Nat Commun. 2017 May 22;8:15497. doi: 10.1038/ncomms15497.
- Background Uher R, Frey BN, Quilty LC, Rotzinger S, Blier P, Foster JA, Muller DJ, Ravindran AV, Soares CN, Turecki G, Parikh SV, Milev R, MacQueen G, Lam RW, Kennedy SH; CAN-BIND Investigator Team. Symptom Dimension of Interest-Activity Indicates Need for Aripiprazole Augmentation of Escitalopram in Major Depressive Disorder: A CAN-BIND-1 Report. J Clin Psychiatry. 2020 Jun 16;81(4):20m13229. doi: 10.4088/JCP.20m13229.
- Background Allen TA, Harkness KL, Lam RW, Milev R, Frey BN, Mueller DJ, Uher R, Kennedy SH, Quilty LC. Interactions between neuroticism and stressful life events predict response to pharmacotherapy for major depression: A CAN-BIND 1 report. Personal Ment Health. 2021 Nov;15(4):273-282. doi: 10.1002/pmh.1514. Epub 2021 May 18.
- Background Nogovitsyn N, Muller M, Souza R, Hassel S, Arnott SR, Davis AD, Hall GB, Harris JK, Zamyadi M, Metzak PD, Ismail Z, Downar J, Parikh SV, Soares CN, Addington JM, Milev R, Harkness KL, Frey BN, Lam RW, Strother SC, Rotzinger S, Kennedy SH, MacQueen GM. Hippocampal tail volume as a predictive biomarker of antidepressant treatment outcomes in patients with major depressive disorder: a CAN-BIND report. Neuropsychopharmacology. 2020 Jan;45(2):283-291. doi: 10.1038/s41386-019-0542-1. Epub 2019 Oct 14.
- Background Chakrabarty T, McInerney SJ, Torres IJ, Frey BN, Milev RV, Muller DJ, Rotzinger S, Kennedy SH, Lam RW; CAN-BIND Investigator Team. Cognitive Outcomes with Sequential Escitalopram Monotherapy and Adjunctive Aripiprazole Treatment in Major Depressive Disorder: A Canadian Biomarker Integration Network in Depression (CAN-BIND-1) Report. CNS Drugs. 2021 Mar;35(3):291-304. doi: 10.1007/s40263-021-00793-1. Epub 2021 Mar 8.
- Background Morton E, Bhat V, Giacobbe P, Lou W, Michalak EE, McInerney S, Chakrabarty T, Frey BN, Milev RV, Muller DJ, Parikh SV, Rotzinger S, Kennedy SH, Lam RW; CAN-BIND Investigator Team. Predictors of Quality of Life Improvement with Escitalopram and Adjunctive Aripiprazole in Patients with Major Depressive Disorder: A CAN-BIND Study Report. CNS Drugs. 2021 Apr;35(4):439-450. doi: 10.1007/s40263-021-00803-2. Epub 2021 Apr 16.
- Background Ayyash S, Davis AD, Alders GL, MacQueen G, Strother SC, Hassel S, Zamyadi M, Arnott SR, Harris JK, Lam RW, Milev R, Muller DJ, Kennedy SH, Rotzinger S, Frey BN, Minuzzi L, Hall GB; CAN-BIND Investigator Team. Exploring brain connectivity changes in major depressive disorder using functional-structural data fusion: A CAN-BIND-1 study. Hum Brain Mapp. 2021 Oct 15;42(15):4940-4957. doi: 10.1002/hbm.25590. Epub 2021 Jul 23.
- Background Caspani G, Turecki G, Lam RW, Milev RV, Frey BN, MacQueen GM, Muller DJ, Rotzinger S, Kennedy SH, Foster JA, Swann JR. Metabolomic signatures associated with depression and predictors of antidepressant response in humans: A CAN-BIND-1 report. Commun Biol. 2021 Jul 22;4(1):903. doi: 10.1038/s42003-021-02421-6.
- Background Allen TA, Lam RW, Milev R, Rizvi SJ, Frey BN, MacQueen GM, Muller DJ, Uher R, Kennedy SH, Quilty LC. Early change in reward and punishment sensitivity as a predictor of response to antidepressant treatment for major depressive disorder: a CAN-BIND-1 report. Psychol Med. 2019 Jul;49(10):1629-1638. doi: 10.1017/S0033291718002441. Epub 2018 Sep 17.
- Background Alders GL, Davis AD, MacQueen G, Strother SC, Hassel S, Zamyadi M, Sharma GB, Arnott SR, Downar J, Harris JK, Lam RW, Milev R, Muller DJ, Ravindran A, Kennedy SH, Frey BN, Minuzzi L, Hall GB; CAN-BIND Investigator Team. Escitalopram ameliorates differences in neural activity between healthy comparison and major depressive disorder groups on an fMRI Emotional conflict task: A CAN-BIND-1 study. J Affect Disord. 2020 Mar 1;264:414-424. doi: 10.1016/j.jad.2019.11.068. Epub 2019 Nov 13.
- Background Chakrabarty T, Harkness KL, McInerney SJ, Quilty LC, Milev RV, Kennedy SH, Frey BN, MacQueen GM, Muller DJ, Rotzinger S, Uher R, Lam RW. Childhood maltreatment and cognitive functioning in patients with major depressive disorder: a CAN-BIND-1 report. Psychol Med. 2020 Nov;50(15):2536-2547. doi: 10.1017/S003329171900268X. Epub 2019 Oct 4.
- Background Dunlop K, Rizvi SJ, Kennedy SH, Hassel S, Strother SC, Harris JK, Zamyadi M, Arnott SR, Davis AD, Mansouri F, Schulze L, Ceniti AK, Lam RW, Milev R, Rotzinger S, Foster JA, Frey BN, Parikh SV, Soares CN, Uher R, Turecki G, MacQueen GM, Downar J. Clinical, behavioral, and neural measures of reward processing correlate with escitalopram response in depression: a Canadian Biomarker Integration Network in Depression (CAN-BIND-1) Report. Neuropsychopharmacology. 2020 Jul;45(8):1390-1397. doi: 10.1038/s41386-020-0688-x.
- Background Yrondi A, Fiori LM, Frey BN, Lam RW, MacQueen GM, Milev R, Muller DJ, Foster JA, Kennedy SH, Turecki G. Association Between Side Effects and Blood microRNA Expression Levels and Their Targeted Pathways in Patients With Major Depressive Disorder Treated by a Selective Serotonin Reuptake Inhibitor, Escitalopram: A CAN-BIND-1 Report. Int J Neuropsychopharmacol. 2020 Feb 1;23(2):88-95. doi: 10.1093/ijnp/pyz066.
- Background McInerney SJ, Chakrabarty T, Maciukiewicz M, Frey BN, MacQueen GM, Milev RV, Ravindran AV, Rotzinger S, Kennedy SH, Lam RW; CAN-BIND Investigator Team. Cognition and Its Association with Psychosocial and Occupational Functioning during Treatment with Escitalopram in Patients with Major Depressive Disorder: A CAN-BIND-1 Report: La Cognition Et Son Association Avec Le Fonctionnement Psychosocial Et Professionnel Durant Le Traitement Par Escitalopram Chez Des Patients Souffrant De Trouble Depressif Majeur: Une Etude Can-Bind-1. Can J Psychiatry. 2021 Sep;66(9):798-806. doi: 10.1177/0706743720974823. Epub 2020 Dec 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Brexpiprazole | Small molecule | 0.5 mg | — |
| Comparator | Brexpiprazole | Small molecule | 2 mg | — |
| Comparator | Escitalopram | Small molecule | 10 mg | — |
| Comparator | Escitalopram | Small molecule | 20 mg | — |