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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole augmentation | Other | This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | varied dose (5, 10, 15 mg qd) for 6 wks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems | The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment. | baseline and 6 weeks |
| Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems | The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment. | baseline and 6 weeks |
| Spatial Working Memory (SWM) Between Errors for 6-move Problems | The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment. | baseline and 6 weeks |
| Spatial Working Memory (SWM) Strategy Score | The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Enjoyment and Satisfaction Questionnaire | The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 752390-9119 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Aripiprazole Augmentation | Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Aripiprazole Augmentation | Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 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 | Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems | The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment. | Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention | Posted | Mean | Standard Deviation | milliseconds | baseline and 6 weeks |
|
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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 | Open-label Aripiprazole Augmentation | Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
Note that because this is an augmentation trial, reported AEs are due to combined treatment with escitalopram, citalopram, or sertraline AND aripiprazole.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Prabha Sunderajan | UT Southwestern Medical Center | 214-648-0156 | prabha.sunderajan@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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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| baseline and 6 weeks |
| 6 weeks |
| Change in Hamilton Rating Scale for Depression (HRSD - 17-item) | The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity. | 6 weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire | The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction. | Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Change in Hamilton Rating Scale for Depression (HRSD - 17-item) | The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity. | Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Primary | Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems | The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment. | Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention | Posted | Mean | Standard Deviation | milliseconds | baseline and 6 weeks |
|
|
|
| Primary | Spatial Working Memory (SWM) Between Errors for 6-move Problems | The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment. | Completers because data were collected pre- and post-treatment | Posted | Mean | Standard Deviation | number of errors | baseline and 6 weeks |
|
|
|
| Primary | Spatial Working Memory (SWM) Strategy Score | The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment. | Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 weeks |
|
|
|
| 0 |
| 17 |
| 14 |
| 17 |
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| palpitations | Cardiac disorders | Systematic Assessment |
|
| dizziness on standing | Cardiac disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| increased perspiration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| tremors | Nervous system disorders | Systematic Assessment |
|
| poor coordination | Nervous system disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| blurred vision | Eye disorders | Systematic Assessment |
|
| ringing in the ears | Ear and labyrinth disorders | Systematic Assessment |
|
| difficulty urinating | Renal and urinary disorders | Systematic Assessment |
|
| general malaise | General disorders | Systematic Assessment |
|
| restlessness | Nervous system disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
|
| decreased energy | General disorders | Systematic Assessment |
|
| painful urination | Renal and urinary disorders | Systematic Assessment |
|
| frequent urination | Renal and urinary disorders | Systematic Assessment |
|
| menstrual irregularity | Reproductive system and breast disorders | Systematic Assessment |
|
| difficulty sleeping | Nervous system disorders | Systematic Assessment |
|
| sleeping too much | Nervous system disorders | Systematic Assessment |
|
| loss of sexual desire | Reproductive system and breast disorders | Systematic Assessment |
|
| trouble achieving orgasm | Reproductive system and breast disorders | Systematic Assessment |
|
| trouble with erections | Reproductive system and breast disorders | Systematic Assessment |
|
| anxiety | Nervous system disorders | Systematic Assessment |
|
| poor concentration | Nervous system disorders | Systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |