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| ID | Type | Description | Link |
|---|---|---|---|
| U01MH062624 | U.S. NIH Grant/Contract | View source | |
| U01MH062565 | U.S. NIH Grant/Contract | View source | |
| U01MH062518 | U.S. NIH Grant/Contract | View source | |
| U01MH062446 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.
Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients.
This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine/sertraline combination | Active Comparator | sertraline plus olanzapine |
|
| olanzapine plus placebo | Placebo Comparator | olanzapine (5 - 20mg/day) plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | 10-20mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial | Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior. | Weeks 1 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on CGI-S Compared to Baseline Over the Course of the Trial | A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient. | Weeks 1 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week. | The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. | Weeks 1 to 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barnett Meyers, MD | Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | United States | ||
| Cornell University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34875106 | Derived | 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. | |
| 29959765 | Derived | 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. |
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Antidepressant and antipsychotic medications being taken at entry were tapered and discontinued prior to randomization. Consented subjects were required to meet criteria for unipolar major depression and have at least one delusion. Subjects were also excluded if an unstable medical condition or evidence of recent substance abuse were present.
Subjects were recruited from the inpatient and outpatient services of four academic sites between December of 2002 and June of 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline Plus Olanzapine | 50-200mg/day sertraline plus 5-20mg/day olanzapine |
| FG001 | Olanzapine Plus Placebo | 5-20mg/day olanzapine plus placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacotherapy | sertraline plus olanzapine |
| BG001 | Monotherapy | placebo plus olanzapine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial | Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior. | Posted | Number | participants | Weeks 1 to 12 |
|
Subjects participated for a maximum of 12 weeks. Study duration of 4.5 years
Extrapyramidal symptoms assessed using the Simpson Angus Scale, incident akathisia using the Barnes Akathisia Scale and tardive dyskinesia was assessed using the Abnormal Involuntary Movement Scale. Changes in UKU measured at each visit. Metabolic labs assessed monthly. Attrition. Other adverse events self-reported throughout study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacotherapy | sertraline plus olanzapine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening depression | Psychiatric disorders | Systematic Assessment | worsening symptoms of depression requiring (re)hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| weight gain | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barnett S. Meyers, MD | Weill Cornell Medical College | 914-997-5721 | bmeyers@med.cornell.edu |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Sertraline | Drug | 150-200mg/day |
|
|
| placebo | Other | tablet that ressembles sertraline but contains no medication |
|
| New York |
| New York |
| 10021 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Toronto | Toronto | Ontario | M5G 2C4 | Canada |
| 28445632 | Derived | 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. |
| 25919834 | Derived | 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. |
| 24229753 | Derived | 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. |
| 23799875 | Derived | 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. |
| 23642462 | Derived | 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. |
| 23609383 | Derived | 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. |
| 22464991 | Derived | 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. |
| 19652123 | Derived | 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. |
| 18724788 | Derived | 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. |
| 18408527 | Derived | 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. |
| 18384244 | Derived | 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. |
| 17335316 | Derived | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
placebo plus olanzapine |
|
|
|
| Secondary | Scores on CGI-S Compared to Baseline Over the Course of the Trial | A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient. | Posted | Mean | Standard Error | units on CGI scale | Weeks 1 to 12 |
|
|
|
|
| Other Pre-specified | Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week. | The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. | Posted | Mean | Standard Error | Scores on Ham-D | Weeks 1 to 12 |
|
|
|
|
| 9 |
| 129 |
| 39 |
| 129 |
| EG001 | Monotherapy | placebo plus olanzapine | 3 | 130 | 35 | 130 |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| broken hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| knee sepsis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| chest pain | Vascular disorders | Non-systematic Assessment |
|
| accidental overdose | General disorders | Non-systematic Assessment |
|
| leg pain/edema | Vascular disorders | Non-systematic Assessment |
|
| fall | General disorders | Systematic Assessment |
|
| sleepiness/sedation | General disorders | Systematic Assessment |
|
| increased lab values | Metabolism and nutrition disorders | Systematic Assessment | triglycerides, cholesterol, LFTs |
|
| reduced sleep | General disorders | Systematic Assessment |
|
| pedal edema/edema | Vascular disorders | Systematic Assessment |
|
| Increased fatigability | General disorders | Systematic Assessment |
|
| increased sleep | General disorders | Systematic Assessment |
|
| increased dream activity | General disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| dizziness/feeling faint | General disorders | Systematic Assessment |
|
| akathisia | Nervous system disorders | Systematic Assessment |
|
| nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| tremor | Nervous system disorders | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |