Major Depressive DisorderNCT00369746
STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse
An observational study of Major Depressive Disorder and Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Alcohol Use Disorder
- What is being tested?
- citalopram
- Type of treatment
- Pill or oral medicine
- How many people
- 674 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the Sequenced Treatment Alternatives to Relieve Depression
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Being tested
- citalopram
- Keywords
- Depression, Alcohol Abuse, Alcohol Dependence
- Medical subject headings
- Depressive Disorder, Major, Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopramDrug
Also called Celexa
tablets, 60 mg maximum, daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: citalopram | |
| Major Depression, citalopram | Patients with major depression, treated with citalopram tablets 20-60 mg daily, for 12 weeks Receives: Drug: citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: study exit visit, at Week 12
Secondary outcomes (4)
Timeline Follow Back (TLFB) Average Drinks Per Drinking Day
This variable reports average drinks/drinking day in a pre-defined time frame.
Measured: 30 days
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
Measured: 30 days
Timeline Follow Back (TLFB) Drinking Days Per 30 Days
This variable reports drinking days in a pre-defined time frame.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Patrick J. McGrath, MD, Study director, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369746
- Sponsor's protocol ID
- #5173
- Other IDs
- R01AA013303
- Status last verified
- Dec 2011
- First submitted
- 24 Aug 2006
- Last updated
- 9 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression
- ClinicalTrials.gov ID
- NCT00369746
- Acronym / sponsor ID
- #5173
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Keywords
- Depression, Alcohol Abuse, Alcohol Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Posted 9 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol and major depression, citalopram | – | Drug: citalopramPatients with alcohol use disorder and major depression, treated with citalopram tablets, 20-60 mg, once daily, for 12 weeks |
| Major Depression, citalopram | – | Drug: citalopramPatients with major depression, treated with citalopram tablets 20-60 mg daily, for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the Sequenced Treatment Alternatives to Relieve Depression
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citalopramAlso: Celexatablets, 60 mg maximum, daily, 12 weeks | Drug | Alcohol and major depression, citalopram, Major Depression, citalopram |
Primary outcome
Quick Inventory of Depression- Self Report 16
Time frame: 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
4 secondary outcomes
Timeline Follow Back (TLFB) Average Drinks Per Drinking Day
Time frame: 30 days
Quantitative Substance Use Inventory ((SUI)
Time frame: 30 days
Timeline Follow Back (TLFB) Drinking Days Per 30 Days
Time frame: 30 days
Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J. McGrath, MD study director
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depression- Self Report 16 (time frame: study exit visit, at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.