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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental | Aripiprazole 5 to 30 mg/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Improvement Scale (CGI) | clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse) | 12 weeks |
| Change in Global Assessment of Functioning Scale (GAFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Hellerstein, MD | NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Evaluation Service, NY State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15588762 | Background | Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8. doi: 10.1016/j.pnpbp.2004.06.016. No abstract available. |
| Label | URL |
|---|---|
| Web Site for the Mood Disorders Research Program, with information about the study and the process of getting involved in research in general and specifically at our site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | aripiprazole augmentation treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | aripiprazole augmentation treatment |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Hamilton Depression Rating Scale (HDRS) | Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12. | Adults with treatment resistant depression, all subjects with data after baseline (14 of 15 subjects). | Posted | Number | participants | 12 weeks |
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16 weeks, during and after the clinical trial
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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 | Aripiprazole | aripiprazole augmentation treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | Nervous system disorders | Non-systematic Assessment |
Open label study without comparison group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hellerstein MD | NY State Psychiatric Institute | 6467748000 | hellers@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.
| baseline and 12 weeks |
| Change in Beck Depression Inventory (BDI) Score | 21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment. | baseline and 12 weeks |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Clinical Global Impressions Improvement Scale (CGI) | clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse) | all subjects for whom data was available after beginning aripiprazole augmentation (14 of 15 subjects) | Posted | Mean | Standard Deviation | units on CGI scale | 12 weeks |
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| Secondary | Change in Global Assessment of Functioning Scale (GAFS) | Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score. | All subjects (14/15) for whom data was available after starting aripiprazole augmentation | Posted | Mean | Standard Deviation | points on GAFS scale | baseline and 12 weeks |
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| Secondary | Change in Beck Depression Inventory (BDI) Score | 21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment. | Number of participants for whom data was available after starting aripiprazole augmentation | Posted | Mean | Standard Deviation | points on BDI scale | baseline and 12 weeks |
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| 0 |
| 15 |
| 8 |
| 15 |
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |