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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA013303 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to determine if having an alcohol use disorder affects recovery from depression, and also whether recovery from depression in patients who have alcohol use disorders is also accompanied by improvement in the alcohol use disorder.
This is an extension of the multi-site sub-study of the National Institute of Mental Health (NIMH) protocol, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), which utilized the infrastructure of the Depression Trials Network to enroll 4,000 subjects diagnosed with Major Depressive Disorder. These subjects initially received 12 weeks of treatment with the anti-depressant citalopram. The thrust of this study was to test treatment algorithms for those subjects who did not respond adequately to initial monotherapy treatment with citalopram or who were unable to tolerate it. The parent protocol also contained several ancillary studies, including a sub-study of subjects with co-morbid alcohol use disorders, which enrolled 130 subjects. Treatment response data was collected at multiple intervals during the 12 week treatment period on depressed subjects both with and without a co-morbid alcohol use disorder.
Comparison: Treatment outcome measures of subjects diagnosed with Major Depressive Disorder will be compared to treatment outcome measures of subjects diagnosed with Major Depressive Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment period. This comparison will show whether having a co-morbid alcohol use disorder affects recovery from depression. In addition, alcohol use data of depressed subjects who demonstrated a positive response to anti-depressant treatment will be compared with alcohol use data of depressed subjects who did not have positive treatment outcomes. This comparison will show whether recovery from depression is associated with improvement in the co-morbid alcohol use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol and major depression, citalopram | Patients with alcohol use disorder and major depression, treated with citalopram tablets, 20-60 mg, once daily, for 12 weeks |
| |
| Major Depression, citalopram | Patients with major depression, treated with citalopram tablets 20-60 mg daily, for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| citalopram | Drug | tablets, 60 mg maximum, daily, 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depression- Self Report 16 | Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit Scale range: Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16 Total scoring ranges (0-48): 0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression | study exit visit, at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Timeline Follow Back (TLFB) Average Drinks Per Drinking Day | This variable reports average drinks/drinking day in a pre-defined time frame. | 30 days |
| Quantitative Substance Use Inventory ((SUI) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in the Sequenced Treatment Alternatives to Relieve Depression
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J. McGrath, MD | New York State Psychiatric Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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Participants were recruited from all participants entering the Sequenced Treatment Alternatives to Relieve Depression clinical trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol Abuse or Dependence | Subjects with alcohol abuse or dependence and Major Depression |
| FG001 | Major Depression Only | Major Depression without alcohol abuse disorder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol Abuse or Dependence | Subjects with alcohol abuse or dependence |
| BG001 | Major Depression Only | Major Depression without alcohol abuse disorder |
| 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 | Quick Inventory of Depression- Self Report 16 | Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit Scale range: Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16 Total scoring ranges (0-48): 0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression | All participants who met entry criteria for alcohol abuse or dependence per protocol. | Posted | Mean | Standard Deviation | units on a scale | study exit visit, at Week 12 |
|
12 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 | Alcohol Abuse or Dependence | Subjects with alcohol abuse or dependence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalilization GMC | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick J. McGrath, M.D. | New York State Psychiatric Institute | 646-774-8076 | mcgrath@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D000437 | Alcoholism |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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Quantitative Substance Use Inventory ((SUI) Measure substance use
Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days
| 30 days |
| Timeline Follow Back (TLFB) Drinking Days Per 30 Days | This variable reports drinking days in a pre-defined time frame. | 30 days |
| Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day | This variable reports maximum drinks per drinking day in a pre-defined time frame. | 30 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects with alcohol abuse or dependence
| OG001 | Major Depression Only | citalopram (Non alcoholic) |
|
|
| Secondary | Timeline Follow Back (TLFB) Average Drinks Per Drinking Day | This variable reports average drinks/drinking day in a pre-defined time frame. | Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol | Posted | Mean | Standard Deviation | drinks per drinking day | 30 days |
|
|
|
| Secondary | Quantitative Substance Use Inventory ((SUI) | Quantitative Substance Use Inventory ((SUI) Measure substance use Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days | All participants who met entry criteria for alcohol abuse or dependence per protocol. | Posted | Mean | Standard Deviation | Days | 30 days |
|
|
|
| Secondary | Timeline Follow Back (TLFB) Drinking Days Per 30 Days | This variable reports drinking days in a pre-defined time frame. | Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| Secondary | Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day | This variable reports maximum drinks per drinking day in a pre-defined time frame. | Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol | Posted | Mean | Standard Deviation | drinks | 30 days |
|
|
|
| 8 |
| 138 |
| 0 |
| 138 |
| EG001 | Major Depression Only | Major Depression without alcohol abuse disorder | 23 | 536 | 0 | 536 |
| Medical illness without hospitalizaiton | General disorders | Non-systematic Assessment |
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| Psychiatric hospitalization, substance abuse | Psychiatric disorders | Non-systematic Assessment |
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| Death, non-suicide | General disorders | Non-systematic Assessment |
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| Psychiatric hospitalization (worsening depression) | Psychiatric disorders | Non-systematic Assessment |
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| Psychiatric hospitalization (Other) | Psychiatric disorders | Non-systematic Assessment |
|
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| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |