drugset / Trial / NCT00056472
Study of Pharmacotherapy of Psychotic Depression
Phase 3
Completed
259 enrolled
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.
Timeline
- Start
- 2003-01
- Primary completion
- 2008-06
- Completion
- 2008-06
Publications
- Kruizinga J, Liemburg E, Burger H, Cipriani A, Geddes J, Robertson L, Vogelaar B, Nolen WA. Pharmacological treatment for psychotic depression. Cochrane Database Syst Rev. 2021 Dec 7;12(12):CD004044. doi: 10.1002/14651858.CD004044.pub5.
- Bingham KS, Meyers BS, Mulsant BH, Rothschild AJ, Whyte EM, Banerjee S, Artis AS, Alexopoulos GS, Flint AJ; STOP-PD Study Group. Stabilization treatment of remitted psychotic depression: the STOP-PD study. Acta Psychiatr Scand. 2018 Sep;138(3):267-273. doi: 10.1111/acps.12937. Epub 2018 Jun 29.
- Bingham KS, Rothschild AJ, Mulsant BH, Whyte EM, Meyers BS, Banerjee S, Szanto K, Flint AJ; STOP-PD Study Group. The Association of Baseline Suicidality With Treatment Outcome in Psychotic Depression. J Clin Psychiatry. 2017 Sep/Oct;78(8):1149-1154. doi: 10.4088/JCP.16m10881.
- Gerretsen P, Flint AJ, Whyte EM, Rothschild AJ, Meyers BS, Mulsant BH. Impaired insight into delusions predicts treatment outcome during a randomized controlled trial for Psychotic Depression (STOP-PD study). J Clin Psychiatry. 2015 Apr;76(4):427-33. doi: 10.4088/JCP.14m09003.
- Deligiannidis KM, Rothschild AJ, Barton BA, Kroll-Desrosiers AR, Meyers BS, Flint AJ, Whyte EM, Mulsant BH; STOP-PD Study Group. A gender analysis of the study of pharmacotherapy of psychotic depression (STOP-PD): gender and age as predictors of response and treatment-associated changes in body mass index and metabolic measures. J Clin Psychiatry. 2013 Oct;74(10):1003-9. doi: 10.4088/JCP.13m08400.
- Ostergaard SD, Meyers BS, Flint AJ, Mulsant BH, Whyte EM, Ulbricht CM, Bech P, Rothschild AJ; STOP-PD Study Group. Measuring psychotic depression. Acta Psychiatr Scand. 2014 Mar;129(3):211-20. doi: 10.1111/acps.12165. Epub 2013 Jun 25.
- Flint AJ, Iaboni A, Mulsant BH, Rothschild AJ, Whyte EM, Meyers BS; STOP-PD Study Group. Effect of sertraline on risk of falling in older adults with psychotic depression on olanzapine: results of a randomized placebo-controlled trial. Am J Geriatr Psychiatry. 2014 Apr;22(4):332-6. doi: 10.1016/j.jagp.2013.01.067. Epub 2013 May 2.
- Blumberger DM, Mulsant BH, Kanellopoulos D, Whyte EM, Rothschild AJ, Flint AJ, Meyers BS. The incidence of tardive dyskinesia in the study of pharmacotherapy for psychotic depression. J Clin Psychopharmacol. 2013 Jun;33(3):391-7. doi: 10.1097/JCP.0b013e31828bf059.
- Weissman J, Flint A, Meyers B, Ghosh S, Mulsant B, Rothschild A, Whyte E; STOP-PD Study Group. Factors associated with non-completion in a double-blind randomized controlled trial of olanzapine plus sertraline versus olanzapine plus placebo for psychotic depression. Psychiatry Res. 2012 May 30;197(3):221-6. doi: 10.1016/j.psychres.2012.02.015. Epub 2012 Mar 31.
- Meyers BS, Flint AJ, Rothschild AJ, Mulsant BH, Whyte EM, Peasley-Miklus C, Papademetriou E, Leon AC, Heo M; STOP-PD Group. A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression: the study of pharmacotherapy of psychotic depression (STOP-PD). Arch Gen Psychiatry. 2009 Aug;66(8):838-47. doi: 10.1001/archgenpsychiatry.2009.79.
- Schaffer A, Flint AJ, Smith E, Rothschild AJ, Mulsant BH, Szanto K, Peasley-Miklus C, Heo M, Papademetriou E, Meyers BS. Correlates of suicidality among patients with psychotic depression. Suicide Life Threat Behav. 2008 Aug;38(4):403-14. doi: 10.1521/suli.2008.38.4.403.
- Smith E, Rothschild AJ, Heo M, Peasley-Miklus C, Caswell M, Papademetriou E, Flint AJ, Mulsant BH, Meyers BS; STOP-PD Collaborative Study Group. Weight gain during olanzapine treatment for psychotic depression: effects of dose and age. Int Clin Psychopharmacol. 2008 May;23(3):130-7. doi: 10.1097/YIC.0b013e3282f424d6.
- Rothschild AJ, Winer J, Flint AJ, Mulsant BH, Whyte EM, Heo M, Fratoni S, Gabriele M, Kasapinovic S, Meyers BS; Study of Pharmacotherapy of Psychotic Depression (STOP-PD) Collaborative Study Group. Missed diagnosis of psychotic depression at 4 academic medical centers. J Clin Psychiatry. 2008 Aug;69(8):1293-6. doi: 10.4088/jcp.v69n0813.
- Andreescu C, Mulsant BH, Peasley-Miklus C, Rothschild AJ, Flint AJ, Heo M, Caswell M, Whyte EM, Meyers BS; STOP-PD Study Group. Persisting low use of antipsychotics in the treatment of major depressive disorder with psychotic features. J Clin Psychiatry. 2007 Feb;68(2):194-200. doi: 10.4088/jcp.v68n0203.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sertraline | Small molecule | 150 mg | — |
| Comparator | Sertraline | Small molecule | 200 mg | — |
| Comparator | Olanzapine | Small molecule | 10 mg | — |
| Comparator | Olanzapine | Small molecule | 20 mg | — |