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Comparison · NCT02129348-b2a634c3

Lithium Treatment Group vs Placebo Group: Clinical Global Impression (CGI) Behavior Change

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Lithium Treatment Group vs Placebo Group: Clinical Global Impression (CGI) Behavior Change. Trial comparisons, record NCT02129348-b2a634c3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02129348-b2a634c3

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3160.1910.475wilson
Risk in group 20.2050.1080.355wilson
Risk difference, group 1 minus group 20.111-0.08470.297newcombe hybrid score
Risk ratio, group 1 over group 21.540.7093.34log
Odds ratio, group 1 over group 21.790.6355.04log
Number needed to treat, for one more participant with the outcome on Lithium Treatment Group than on Placebo Group9.04from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Lithium Treatment Group
The patient will be started on lithium 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on lithium blood level. Blood will be drawn at each study visit. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Lithium
1238OG000
Group 2Placebo Group
The patient will be started on placebo 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on sham lithium blood level. Blood will be drawn for sham lithium levels at weeks 2, 4, 6, 8, and 12. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Placebo
839OG001

Outcome

Type
SECONDARY
Title
Clinical Global Impression (CGI) Behavior Change
Description
Clinical Global Impression (CGI) Behavior Change score is the measure used to assess change in overall behavior; scoring range 1-7 with higher scores indicating worsening over time and lower scores indicating improvement over time. Scores ranging from 1-3 indicate improvement. Only patients that demonstrated improvement at week 12 were reported; scores for earlier weeks were only used to assess progress throughout the study.
Time frame
Week 12
Population

Source ClinicalTrials.gov

Trial

Title
Treatment of Psychosis and Agitation in Alzheimer's Disease
NCT number
NCT02129348
Phases
PHASE2
Conditions
Alzheimer's Disease, Psychosis, Agitation
Interventions
Lithium, Placebo
Lead sponsor
New York State Psychiatric Institute
Results first posted
2021-08-16

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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