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Study Title and Description

Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults
Author Delbello M
Country
Year 2017
Numbers Pubmed ID: NCT00550394

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


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Quetiapine_Placebo
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2 Quetiapine_Topiramate
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Design Details
Question... Follow Up Answer Follow-up Answer
Should this citation be included? ... Why defer? Defer decision ... only 14 completed 9 in 1 arm and 5 in the other
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Does this paper originate from a primary study of interest? ... Trial registry number ... NCT00550394
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Ages eligible (in years) 12
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25
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Total sample size (in all arms) 39 (14 completed)
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Age distribution of enrolled population (in years) 17.9
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Substance used Alcohol
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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) 2.7
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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: Adverse event      Population: All Participants
Time Point Measure Quetiapine_Placebo Quetiapine_Topiramate


4 months

N Analyzed 21 18
Counts 8 2
Outcome: Adverse event      Population: All Participants
Time Point Measure Quetiapine_Placebo Quetiapine_Topiramate


4 months

N Analyzed 21 18
Counts 1 0
Outcome: Adverse event      Population: All Participants
Time Point Measure Quetiapine_Placebo Quetiapine_Topiramate


4 months

N Analyzed 21 18
Counts 4 11
Outcome: Adverse event      Population: All Participants
Time Point Measure Quetiapine_Placebo Quetiapine_Topiramate


4 months

N Analyzed 21 18
Counts 3 9
Outcome: alcohol use days      Population: All Participants
Time Point Measure Quetiapine_Placebo Quetiapine_Topiramate


0 months

N Analyzed 21 18
Mean
SD
SE


4 months

N Analyzed 21 18
Mean
SD
SE
Outcome: heavy drinking days      Population: All Participants
Time Point Measure Quetiapine_Placebo Quetiapine_Topiramate


0 months

N Analyzed 21 18
Mean
SD
SE


4 months

N Analyzed 21 18
Mean
SD
SE


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation No
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators Unsure Insufficient data to assess
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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
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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 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 High 64% loss
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting need to check drinks/day, drinks/day on drinking days, abstinence, heavy drinking days
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Quality Rating
No quality rating data was found.