Psychotic Depression
Conditions
Brief summary
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.
Interventions
DRUGAripiprazole
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.
Sponsors
Bristol-Myers Squibb
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women aged 18-80 years, inclusive. 2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with psychotic features. 3. Inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved SSRI's and abilify. 4. HAM-D-24 score \> 16.
Exclusion criteria
1. Pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed). 2. Women who are breast-feeding. 3. Patients meeting DSM-IV criteria for major depression without psychotic features, or psychosis without major depression at the screen visit. 4. Patients with serious suicidal risk. 5. Patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function. 6. Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder. 7. Patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. If patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study. 8. Patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression and Psychosis Response Rate | Baseline and 7 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression and Psychosis Remission Rate | Baseline and 7 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment ran from Sept. 13, 2004 to Aug. 9, 2006 from the Massachusetts General Psychiatry Inpatient and Outpatient clinics.
Pre-assignment details
All participants enrolled in the study were given aripiprazole and escitalopram.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Major Depression With Psychotic Features |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age Continuous | 41.8 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 16 |
| serious Total, serious adverse events | 2 / 16 |
Outcome results
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.
Time frame: Baseline and 7 weeks
Population: For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Major Depression With Psychotic Features | Depression and Psychosis Response Rate | 62.5 percent of participants | 8.3 |
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.
Time frame: Baseline and 7 weeks
Population: For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Major Depression With Psychotic Features | Depression and Psychosis Remission Rate | 50 percent of participants |