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Study Title and Description

Double-blind fluoxetine trial in comorbid MDD-CUD youth and young adults.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Double-blind fluoxetine trial in comorbid MDD-CUD youth and young adults.
Author Cornelius JR., Bukstein OG., Douaihy AB., Clark DB., Chung TA., Daley DC., Wood DS., Brown SJ.
Country Department of Psychiatry, University of Pittsburgh School of Medicine, PAARC Suite, Pittsburgh, PA 15213, USA. corneliusjr@upmc.edu
Year 2010
Numbers Pubmed ID: 20576364

Secondary Publication Information
UI Title Author Country Year
TREATMENT TRIAL AND LONG-TERM FOLLOW-UP EVALUATION AMONG COMORBID YOUTH WITH MAJOR DEPRESSION AND A CANNABIS USE DISORDER. Cornelius JR., Salloum IM., Ferrell R., Douaihy AB., Hayes J., Kirisci L., Horner M., Daley DC. -- Not Found -- 2012
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Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence Cornelius 2013
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Fluoxetine_CBT_MI
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2 Placebo_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? ... PMID ... 25328373
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Ages eligible (in years) 14
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15
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Total sample size (in all arms) 70
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Age distribution of enrolled population (in years) 21.1
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Substance used Cannabis
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Cannabis
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Interventions studied? Pharmacologic
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No active treatment
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Pharmacologic
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No active treatment
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Outcome? Self report of use/abstinence and/or intensity
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Mental health
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Adverse effects
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Self report 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) 2.4
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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
P-Value P-Value
Outcome: BDI      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure


0 weeks

N Analyzed 34 36 nr
Mean 18.06 16.64
SD 8.8 9.85


12 weeks

N Analyzed 34 36 0.803
Mean 7.79 7.31
SD 7.98 8.29
P-Value P-Value
Outcome: cannabis abuse sxs      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure Fluoxetine_CBT_MI vs. Placebo_CBT_MI


0 weeks

N Analyzed 34 36 nr
Mean 1.35 1.19
SD 1.01 0.86


12 weeks

N Analyzed 34 36 0.476
Mean 0.59 0.47
SD 0.79 0.65
P-Value P-Value
Outcome: cannabis dep sxs      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure Fluoxetine_CBT_MI vs. Placebo_CBT_MI


0 weeks

N Analyzed 34 36 nr
Mean 4.88 5.19
SD 1.63 1.35


12 weeks

N Analyzed 34 36 0.738
Mean 3.29 3.14
SD 2.11 1.74
P-Value P-Value
Outcome: alcohol abuse sxs      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure Fluoxetine_CBT_MI vs. Placebo_CBT_MI


0 weeks

N Analyzed 34 36 nr
Mean 0.32 0.33
SD 0.59 0.72


12 weeks

N Analyzed 34 36 0.349
Mean 0.24 0.14
SD 0.5 0.35
P-Value P-Value
Outcome: alcohol dep sxs      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure Fluoxetine_CBT_MI vs. Placebo_CBT_MI


0 weeks

N Analyzed 34 36 nr
Mean 1.24 1
SD 1.62 1.43


12 weeks

N Analyzed 34 36 0.678
Mean 0.65 0.75
SD 0.81 1.2
P-Value P-Value
Outcome: heavy drinking days      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure Fluoxetine_CBT_MI vs. Placebo_CBT_MI


0 weeks

N Analyzed 34 36 nr
Mean 0.77 0.63
SD 0.98 0.91


12 weeks

N Analyzed 43 36 0.367
Mean 0.74 0.51
SD 1.07 0.81
P-Value P-Value
Outcome: alcohol drinks      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure Fluoxetine_CBT_MI vs. Placebo_CBT_MI


0 weeks

N Analyzed 34 36 nr
Mean 4.95 4.21
SD 3.31 2.36


12 weeks

N Analyzed 34 36 0.399
Mean 3.88 3.2
SD 3.87 2.73
P-Value P-Value
Outcome: cannabis use days      Population: All Participants Between-Arm Comparisons
Time Point Measure Fluoxetine_CBT_MI Placebo_CBT_MI Comparison Measure Fluoxetine_CBT_MI vs. Placebo_CBT_MI


0 weeks

N Analyzed 34 36 n4
Mean 4.61 4.35
SD 2.18 1.93


12 weeks

N Analyzed 34 36 0.182
Mean 3.88 3.1
SD 2.6 2.27


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 Data Pill counts done but 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 Urn
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Unclear
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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 0%
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting need to check Per NCT00149643: Days of use, Depression symptoms (BDI), CUD criteria met
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Quality Rating
No quality rating data was found.