Alcohol Use Disorder, Major Depressive Disorder
Conditions
Keywords
Depression, Alcohol Abuse, Alcohol Dependence
Brief summary
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.
Detailed description
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.
Interventions
DRUGcitalopram
tablets, 60 mg maximum, daily, 12 weeks
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
New York State Psychiatric Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18- 75 years * Meets criteria for Non-psychotic Major Depression * Signs informed consent and able to comply with study * Hamilton Depression Scale (HAM-D 17) \>14 * Endorses any drinking items on Short Michigan Alcoholism Screening Test
Exclusion criteria
* Pregnant women and women of childbearing potential who are not using a medically accepted means of contraception. * Women who are breast feeding * Patients with suicidal ideation that require hospitalization * Patients with unstable physical disorders * Patients with a history of allergy to citalopram or history of non-response to an adequate dose of citalopram in the current episode. * Patients meeting criteria for the following diagnoses as a primary condition: Schizophrenia, Schizoaffective Disorder, Bipolar I, II, and Not Otherwise Specified, Anorexia nervosa, Bulimia, Obsessive Compulsive Disorder * Patients abusing substances which require detoxification. American Society for Addiction Medicine standards for detoxification will be used (Level III.7). Patients with substance abuse who are in substance abuse treatment will be eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depression- Self Report 16 | study exit visit, at Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timeline Follow Back (TLFB) Average Drinks Per Drinking Day | 30 days | This variable reports average drinks/drinking day in a pre-defined time frame. |
| Quantitative Substance Use Inventory ((SUI) | 30 days | Quantitative Substance Use Inventory ((SUI) Measure substance use Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days |
| Timeline Follow Back (TLFB) Drinking Days Per 30 Days | 30 days | This variable reports drinking days in a pre-defined time frame. |
| Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day | 30 days | This variable reports maximum drinks per drinking day in a pre-defined time frame. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from all participants entering the Sequenced Treatment Alternatives to Relieve Depression clinical trial.
Participants by arm
| Arm | Count |
|---|---|
| Alcohol Abuse or Dependence Subjects with alcohol abuse or dependence | 138 |
| Major Depression Only Major Depression without alcohol abuse disorder | 536 |
| Total | 674 |
Baseline characteristics
| Characteristic | Major Depression Only | Alcohol Abuse or Dependence | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 536 Participants | 138 Participants | 674 Participants |
| Age, Continuous | 39.5 years STANDARD_DEVIATION 13.4 | 36.7 years STANDARD_DEVIATION 12.3 | 38.9 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment United States | 536 participants | 138 participants | 674 participants |
| Sex: Female, Male Female | 134 Participants | 77 Participants | 211 Participants |
| Sex: Female, Male Male | 402 Participants | 61 Participants | 463 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 138 | 0 / 536 |
| serious Total, serious adverse events | 8 / 138 | 23 / 536 |
Outcome results
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
Time frame: study exit visit, at Week 12
Population: All participants who met entry criteria for alcohol abuse or dependence per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcoholic | Quick Inventory of Depression- Self Report 16 | 9.3 units on a scale | Standard Deviation 6.1 |
| Major Depression Only | Quick Inventory of Depression- Self Report 16 | 8.9 units on a scale | Standard Deviation 5.7 |
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
Time frame: 30 days
Population: All participants who met entry criteria for alcohol abuse or dependence per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcoholic | Quantitative Substance Use Inventory ((SUI) | 2.4 Days | Standard Deviation 7.12 |
Secondary
Timeline Follow Back (TLFB) Average Drinks Per Drinking Day
This variable reports average drinks/drinking day in a pre-defined time frame.
Time frame: 30 days
Population: Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcoholic | Timeline Follow Back (TLFB) Average Drinks Per Drinking Day | 2.9 drinks per drinking day | Standard Deviation 2.6 |
Secondary
Timeline Follow Back (TLFB) Drinking Days Per 30 Days
This variable reports drinking days in a pre-defined time frame.
Time frame: 30 days
Population: Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcoholic | Timeline Follow Back (TLFB) Drinking Days Per 30 Days | 8.1 days | Standard Deviation 7.8 |
Secondary
Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day
This variable reports maximum drinks per drinking day in a pre-defined time frame.
Time frame: 30 days
Population: Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcoholic | Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day | 4.9 drinks | Standard Deviation 3.9 |