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Study Title and Description

Double-blind placebo-controlled trial of fluoxetine in adolescents with comorbid major depression and an alcohol use disorder.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Double-blind placebo-controlled trial of fluoxetine in adolescents with comorbid major depression and an alcohol use disorder.
Author Cornelius JR., Bukstein OG., Wood DS., Kirisci L., Douaihy A., Clark DB.
Country University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, 3811 O'Hara Street, Pittsburgh PA 15213, USA. corneliusjr@upmc.edu
Year 2009
Numbers Pubmed ID: 19321268

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Placebo_CBT_MI
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2 Fluoxetine_CBT_MI
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Design Details
Question... Follow Up Answer Follow-up Answer
Should this citation be included? Yes
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Does this paper originate from a primary study of interest? No
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Ages eligible (in years) 15
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20
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Total sample size (in all arms) 50
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Age distribution of enrolled population (in years)
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Substance used Alcohol
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Alcohol
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Interventions studied? Combined behavioral and pharmacologic
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Combined behavioral and pharmacologic
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Outcome? Objective measurement of use/abstinence and/or intensity
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Mental health
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Adverse effects
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Objective measurement of use/abstinence and/or intensity
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Mental health
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Adverse effects
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Age variation of enrolled population (in years) nd
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nd
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nd
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nd
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nd
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Study type RCT
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Is any arm a brief intervention (or single session)? No
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Income level of country(ies) of origin Upper income
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Upper income
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Results & Comparisons


Results Data
Outcome: alcohol use days      Population: All Participants
Time Point Measure Placebo_CBT_MI Fluoxetine_CBT_MI


0 months

N Analyzed 26 24
Mean 3.19 3.01
SD 1.35 1.75


3 months

N Analyzed 26 24
Mean 1.87 1.88
SD 1.43 1.52
Outcome: heavy drinking days      Population: All Participants
Time Point Measure Placebo_CBT_MI Fluoxetine_CBT_MI


0 months

N Analyzed 26 24
Mean 2.28 1.70
SD 1.01 1.07


3 months

N Analyzed 26 24
Mean 1.35 1.04
SD 1.21 1.15
Outcome: BDI      Population: All Participants
Time Point Measure Placebo_CBT_MI Fluoxetine_CBT_MI


0 months

N Analyzed 26 24
Mean 22.12 17.25
SD 7.50 8.87


3 months

N Analyzed 26 24
Mean 10.46 6.79
SD 10.80 7.49
Outcome: alcohol sxs      Population: All Participants
Time Point Measure Placebo_CBT_MI Fluoxetine_CBT_MI


0 months

N Analyzed 26 24
Mean 5.38 5.08
SD 2.32 2.34


3 months

N Analyzed 26 24
Mean 2.85 2.42
SD 2.96 2.04


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation Yes
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators No Depression, not clearly accounted for. Heavy drinking also near significant (0.053)
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups No
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups No Data Did pill counts, not results not reported
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Timing of outcome assessments (detection bias): Detection bias because important outcomes were not measured at the same time across groups Yes
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Additional Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. No
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Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Low
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low
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Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study Low
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Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. Low
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Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Low
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low Although 3/26 (placebo) vs. 0/24 stopped Rx due to physician decision
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting need to check NCT00027378: Alcohol use (TFB), Depression (BDI)
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Quality Rating
No quality rating data was found.