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Study Title and Description

The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial.
Author Findling RL., Pagano ME., McNamara NK., Stansbrey RJ., Faber JE., Lingler J., Demeter CA., Bedoya D., Reed MD.
Country Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, Ohio, USA. robert.findling@uhhospitals.org
Year 2009
Numbers Pubmed ID: 19298659

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


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Fluoxetine
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2 Placebo
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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) 12
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17
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Total sample size (in all arms) 34
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Age distribution of enrolled population (in years) 16.46
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Substance used Alcohol
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Cannabis
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Interventions studied? Pharmacologic
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Outcome? Self report of use/abstinence and/or intensity
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Age variation of enrolled population (in years) 1.08
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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 ... Country(ies) name(s) Unclear ... United States
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Results & Comparisons


Results Data
Outcome: pct abstinent for nos      Population: All Participants
Time Point Measure Fluoxetine Placebo


0 weeks

Percentage 18 25
N Analyzed 18 16


2 weeks

Percentage 40 55
N Analyzed 18 16


4 weeks

Percentage 38 43
N Analyzed 18 16


8 weeks

Percentage 30 25
N Analyzed 12 13
Mean Difference 95% CI low 95% CI high P-Value Mean Difference 95% CI low 95% CI high P-Value
Outcome: depression      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine Placebo Comparison Measure Fluoxetine vs. Placebo


0 weeks

N Analyzed 18 16 nr
Mean 53 53.94 nr
SD 2.32 2.46 nr
nr


8 weeks

N Analyzed 18 16 -4.23
Mean 34.6 31.31 -12.95
SD 3.22 3.42 4.49
0.33


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 Yes
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups No
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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 I made the jump that the permuted block randomization was good enough because they mentioned "adequate non-predictability"
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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. High They say double-blind, but the treating physician could double the dose 4 weeks into the treatment. Therefore, I'm assuming the physician knew.
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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 High
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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Quality Rating
No quality rating data was found.