Trial Outcomes & Findings for STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse (NCT NCT00369746)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

674 participants

Primary outcome timeframe

study exit visit, at Week 12

Results posted on

2014-05-09

Participant Flow

Participants were recruited from all participants entering the Sequenced Treatment Alternatives to Relieve Depression clinical trial.

Participant milestones

Participant milestones
Measure	Alcohol Abuse or Dependence Subjects with alcohol abuse or dependence and Major Depression	Major Depression Only Major Depression without alcohol abuse disorder
Overall Study STARTED	138	536
Overall Study COMPLETED	138	536
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcohol Abuse or Dependence n=138 Participants Subjects with alcohol abuse or dependence	Major Depression Only n=536 Participants Major Depression without alcohol abuse disorder	Total n=674 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	138 Participants n=5 Participants	536 Participants n=7 Participants	674 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	39.5 years STANDARD_DEVIATION 13.4 • n=7 Participants	38.9 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	134 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	402 Participants n=7 Participants	463 Participants n=5 Participants
Region of Enrollment United States	138 participants n=5 Participants	536 participants n=7 Participants	674 participants n=5 Participants

PRIMARY outcome

Timeframe: study exit visit, at Week 12

Population: All participants who met entry criteria for alcohol abuse or dependence per protocol.

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

Outcome measures

Outcome measures
Measure	Alcoholic n=138 Participants Subjects with alcohol abuse or dependence	Major Depression Only n=536 Participants citalopram (Non alcoholic)
Quick Inventory of Depression- Self Report 16	9.3 units on a scale Standard Deviation 6.1	8.9 units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: 30 days

Population: Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol

This variable reports average drinks/drinking day in a pre-defined time frame.

Outcome measures

Outcome measures
Measure	Alcoholic n=138 Participants Subjects with alcohol abuse or dependence	Major Depression Only citalopram (Non alcoholic)
Timeline Follow Back (TLFB) Average Drinks Per Drinking Day	2.9 drinks per drinking day Standard Deviation 2.6	—

SECONDARY outcome

Timeframe: 30 days

Population: All participants who met entry criteria for alcohol abuse or dependence per protocol.

Quantitative Substance Use Inventory ((SUI) Measure substance use Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days

Outcome measures

Outcome measures
Measure	Alcoholic n=138 Participants Subjects with alcohol abuse or dependence	Major Depression Only citalopram (Non alcoholic)
Quantitative Substance Use Inventory ((SUI)	2.4 Days Standard Deviation 7.12	—

SECONDARY outcome

Timeframe: 30 days

Population: Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol

This variable reports drinking days in a pre-defined time frame.

Outcome measures

Outcome measures
Measure	Alcoholic n=138 Participants Subjects with alcohol abuse or dependence	Major Depression Only citalopram (Non alcoholic)
Timeline Follow Back (TLFB) Drinking Days Per 30 Days	8.1 days Standard Deviation 7.8	—

SECONDARY outcome

Timeframe: 30 days

Population: Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol

This variable reports maximum drinks per drinking day in a pre-defined time frame.

Outcome measures

Outcome measures
Measure	Alcoholic n=138 Participants Subjects with alcohol abuse or dependence	Major Depression Only citalopram (Non alcoholic)
Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day	4.9 drinks Standard Deviation 3.9	—

Adverse Events

Alcohol Abuse or Dependence

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Major Depression Only

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alcohol Abuse or Dependence n=138 participants at risk Subjects with alcohol abuse or dependence	Major Depression Only n=536 participants at risk Major Depression without alcohol abuse disorder
General disorders Hospitalilization GMC	3.6% 5/138 • Number of events 5 • 12 weeks	3.0% 16/536 • Number of events 16 • 12 weeks
General disorders Medical illness without hospitalizaiton	0.72% 1/138 • Number of events 1 • 12 weeks	0.19% 1/536 • Number of events 1 • 12 weeks
Psychiatric disorders Psychiatric hospitalization, substance abuse	1.4% 2/138 • Number of events 2 • 12 weeks	0.19% 1/536 • Number of events 1 • 12 weeks
General disorders Death, non-suicide	0.00% 0/138 • 12 weeks	0.19% 1/536 • Number of events 1 • 12 weeks
Psychiatric disorders Psychiatric hospitalization (worsening depression)	0.00% 0/138 • 12 weeks	0.37% 2/536 • Number of events 2 • 12 weeks
Psychiatric disorders Psychiatric hospitalization (Other)	0.00% 0/138 • 12 weeks	0.37% 2/536 • Number of events 2 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Patrick J. McGrath, M.D.

New York State Psychiatric Institute

Phone: 646-774-8076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place