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Study Title and Description

Double-blind and placebo-controlled study of lithium for adolescent bipolar disorders with secondary substance dependency.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Double-blind and placebo-controlled study of lithium for adolescent bipolar disorders with secondary substance dependency.
Author Geller B., Cooper TB., Sun K., Zimerman B., Frazier J., Williams M., Heath J.
Country Washington University School of Medicine, St. Louis, MO 63110, USA.
Year 1998
Numbers Pubmed ID: 9473913

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


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Lithium
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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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Ages eligible (in years) 12
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18
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Total sample size (in all arms) 25
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Age distribution of enrolled population (in years) 16.3
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Substance used Alcohol
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Cannabis
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Other ... Cough syrup, Inhalant
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Interventions studied? Behavioral
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Pharmacologic
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Outcome? Objective measurement of use/abstinence and/or intensity
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Substance-related problems or symptoms scale
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Mental health
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Adverse effects
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Other ... serum lithium level, pregnancy test in females, pill count
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Age variation of enrolled population (in years) 1.2
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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: pct abstinent for nos      Population: All Participants
Time Point Measure Lithium Placebo


3 weeks

Percentage 60 60
N Analyzed 13 12


4 weeks

Percentage 85 60
N Analyzed 13 12


5 weeks

Percentage 84 50
N Analyzed 13 12


6 weeks

Percentage 90 65
N Analyzed 13 12
P-Value
Outcome: CGAS >=65.      Population: All Participants Between-Arm Comparisons
Time Point Measure Lithium Placebo Comparison Measure Lithium vs. Placebo


6 weeks

Percentage 46.2 8.3 0.046
N Analyzed 13 12


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 Adjusted
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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 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 16%
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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.