Publications

World-Class Services for Drug Development and Clinical Trial Success

How should we design future mechanistic and/ or efficacy clinical trials?

Success and efficiency of phase 2/3 adjunctive trials for MDD funded by industry: a systematic review

Salloum NC, Fava M, Ball S, Papakostas GI.Mol Psychiatry. 2020 Sep;25(9):1967-1974. doi: 10.1038/s41380-020-0646-3. Epub 2020 Jan 27.PMID: 31988433

Randomized, controlled, participant- and rater-blind trial of pharmacogenomic test-guided treatment versus treatment as usual for major depressive disorder

Clinical Trial Methodologies

Perlis RH, Dowd D, Fava M, Lencz T, Krause DS.Depress Anxiety. 2020 Sep;37(9):834-841. doi: 10.1002/da.23029. Epub 2020 May 7.PMID: 32383277 Clinical Trial.

Efficacy and safety of TS-121, a novel vasopressin V 1B receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study

Clinical Trial Methodologies

Kamiya M, Sabia HD, Marella J, Fava M, Nemeroff CB, Umeuchi H, Iijima M, Chaki S, Nishino I.J Psychiatr Res. 2020 Sep;128:43-51. doi: 10.1016/j.jpsychires.2020.05.017. Epub 2020 May 31.PMID: 32521250 Free article. Clinical Trial.

Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: secondary analysis of the clarity study

Clinical Trial Results

Papakostas GI, Fava M, Freeman MP, Shelton RC, Thase ME, Jha MK, Trivedi MH, Dirks B, Liu K, Stankovic S.Int Clin Psychopharmacol. 2020 Nov;35(6):313-321. doi: 10.1097/YIC.0000000000000328.PMID: 32804742

Vortioxetine Versus Placebo for Major Depressive Disorder: A Comprehensive Analysis of the Clinical Trial Dataset

Meta Analyses

Iovieno N, Papakostas GI, Feeney A, Fava M, Mathew SJ, Iosifescu DI, Murrough JW, Macaluso M, Hock RS, Jha MK.J Clin Psychiatry. 2021 Jun 15;82(4):20r13682. doi: 10.4088/JCP.20r13682.PMID: 34133089

The effect of single administration of intravenous ketamine augmentation on suicidal ideation in treatment-resistant unipolar depression: Results from a randomized double-blind study

Clinical Trial Results

Feeney A, Hock RS, Freeman MP, Flynn M, Hoeppner B, Iosifescu DV, Trivedi MH, Sanacora G, Mathew SJ, Debattista C, Ionescu DF, Fava M, Papakostas GI.Eur Neuropsychopharmacol. 2021 Aug;49:122-132. doi: 10.1016/j.euroneuro.2021.04.024. Epub 2021 Jun 3.PMID: 34090255

REL-1017 (Esmethadone) as Adjunctive Treatment in Patients With Major Depressive Disorder: A Phase 2a Randomized Double-Blind Trial

Clinical Trial Results

Fava M, Stahl S, Pani L, De Martin S, Pappagallo M, Guidetti C, Alimonti A, Bettini E, Mangano RM, Wessel T, de Somer M, Caron J, Vitolo OV, Gilbert A, Mehta H, Kearney M, Mattarei A, Gentilucci M, Folli F, Traversa S, Inturrisi CE, Manfredi PL.Am J Psychiatry. 2021 Dec 22:appiajp202121020197. doi: 10.1176/appi.ajp.2021.21020197. Online ahead of print.PMID: 34933568

Pimavanserin for negative symptoms of schizophrenia: results from the ADVANCE phase 2 randomised, placebo-controlled trial in North America and Europe

Clinical Trial Results

Bugarski-Kirola D, Arango C, Fava M, Nasrallah H, Liu IY, Abbs B, Stankovic S.Lancet Psychiatry. 2022 Jan;9(1):46-58. doi: 10.1016/S2215-0366(21)00386-2. Epub 2021 Nov 30.PMID: 34861170

Deception and Study Participation—Unintended Influences and Ramifications for Clinical Trials

Clinical Trial Results

Marlene P. Freeman, MD

January 25, 2019. doi:10.1001/jamanetworkopen.2018.7359