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Study Title and Description

A randomized controlled trial of fluoxetine and cognitive behavioral therapy in adolescents with major depression, behavior problems, and substance use disorders.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title A randomized controlled trial of fluoxetine and cognitive behavioral therapy in adolescents with major depression, behavior problems, and substance use disorders.
Author Riggs PD., Mikulich-Gilbertson SK., Davies RD., Lohman M., Klein C., Stover SK.
Country Department of Psychiatry, University of Colorado at Denver and Health Sciences Center, Denver, CO 80262, USA. paula.riggs@uchsc.edu
Year 2007
Numbers Pubmed ID: 17984403

Secondary Publication Information
UI Title Author Country Year
How adolescents with substance use disorder spend research payments. Thurstone C., Salomensen-Sautel S., Riggs PD. Denver Health and Hospital Authority, University of Denver, 1155 Cherokee Street, MC 3440, Denver, CO 80204, USA. Christian.Thurstone@dhha.org 2010
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Fluoxetine_CBT
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2 Placebo_CBT
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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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No
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Ages eligible (in years) 14
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16
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Total sample size (in all arms) 192
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Age distribution of enrolled population (in years) 14.3
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Substance used Alcohol
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Cannabis
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Opioid
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Stimulant
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Alcohol
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Cannabis
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Opioid
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Stimulant
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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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Self report of use/abstinence and/or intensity
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Other ... depression symptoms
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Age variation of enrolled population (in years) 1.5
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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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Results & Comparisons


Results Data
Outcome: nos use days      Population: All Participants
Time Point Measure Fluoxetine_CBT Placebo_CBT


0 weeks

Mean 17.18 17.1
95% CI low 14.73 14.68
95% CI high 19.62 19.52
N Analyzed 63 63


4 weeks

Mean 15.66 13.69
95% CI low 13.29 11.34
95% CI high 18.04 16.03
N Analyzed 63 63


8 weeks

Mean 14.51 11.77
95% CI low 12.06 9.34
95% CI high 16.96 14.2
N Analyzed 63 63


12 weeks

Mean 13.70 11.35
95% CI low 11.15 8.8
95% CI high 16.25 13.89
N Analyzed 63 63


16 weeks

Mean 13.24 12.41
95% CI low 9.98 9.17
95% CI high 16.51 15.66
N Analyzed 63 63
Outcome: depression      Population: All Participants
Time Point Measure Fluoxetine_CBT Placebo_CBT


0 weeks

Mean 50.75 49.44
95% CI low 48.04 46.74
95% CI high 53.45 52.14
N Analyzed 63 63


4 weeks

Mean 38.14 38.59
95% CI low 35.85 36.31
95% CI high 40.42 40.88
N Analyzed 63 63


8 weeks

Mean 29.81 31.83
95% CI low 27.73 29.76
95% CI high 31.88 33.91
N Analyzed 63 63


12 weeks

Mean 25.76 29.15
95% CI low 23.78 27.18
95% CI high 27.73 31.12
N Analyzed 63 63


16 weeks

Mean 25.99 30.55
95% CI low 23.1 27.69
95% CI high 28.88 33.42
N Analyzed 63 63


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 Yes
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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 Unclear
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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
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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.