Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major Depression with Psychotic Features | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study. Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia. You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression and Psychosis Response Rate | This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. | Baseline and 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression and Psychosis Remission Rate | This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. | Baseline and 7 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthews D John, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19142112 | Derived | Matthews JD, Siefert C, Dording C, Denninger JW, Park L, van Nieuwenhuizen AO, Sklarsky K, Hilliker S, Homberger C, Rooney K, Fava M. An open study of aripiprazole and escitalopram for psychotic major depressive disorder. J Clin Psychopharmacol. 2009 Feb;29(1):73-6. doi: 10.1097/JCP.0b013e318193dfb4. |
Not provided
Not provided
All participants enrolled in the study were given aripiprazole and escitalopram.
Recruitment ran from Sept. 13, 2004 to Aug. 9, 2006 from the Massachusetts General Psychiatry Inpatient and Outpatient clinics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Major Depression With Psychotic Features | All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Major Depression With Psychotic Features | All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks. |
| 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 | Depression and Psychosis Response Rate | This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. | For the 3 participants who did not complete the study, the "last observation carried forward" technique was used to replace missing data for them. | Posted | Number | percent of participants | Baseline and 7 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Major Depression With Psychotic Features | All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthostatic hypotension | Vascular disorders | Systematic Assessment | 1 subject had a severe orthostatic drop in her blood pressure requiring an ED visit while on aripiprazole 15mg a day, escitalopram 10 mg a day, and propanolol 10 mg 3 times a day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | Systematic Assessment |
We had several limitations to the study. The sample size was small, and we used an open and uncontrolled study design. We also excluded subjects who currently or recently abused alcohol, recreational drugs, and/or prescription drugs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Matthews | Massachusetts General Hospital | 617-724-0847 | jmatthews@partners.org |
Not provided
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Depression and Psychosis Remission Rate | This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. | For the 3 participants who did not complete the study, the "last observation carried forward" technique was used to replace missing data for them. | Posted | Number | percent of participants | Baseline and 7 weeks |
|
|
|
| 2 |
| 16 |
| 16 |
| 16 |
|
| worsening of major depression with psychotic features | Psychiatric disorders | Systematic Assessment | 1 subject had to be hospitalized for worsening of major depression with psychotic features. |
|
| Gastrointestinal distress | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Sedation | General disorders | Systematic Assessment |
|
| Body aches | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |