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Comparison · NCT01256177-dd2f3545

Quetiapine XR vs Placebo: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)

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

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ConductScience Library. Quetiapine XR vs Placebo: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment). Trial comparisons, record NCT01256177-dd2f3545. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01256177-dd2f3545

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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 10.6330.550.709wilson
Risk in group 20.4210.3430.504wilson
Risk difference, group 1 minus group 20.2120.09460.321newcombe hybrid score
Risk ratio, group 1 over group 21.51.191.89log
Odds ratio, group 1 over group 22.371.463.83log
Number needed to treat, for one more participant with the outcome on Quetiapine XR than on Placebo4.723.1210.6from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Quetiapine XRQuetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.88139OG001
Group 2PlaceboPlacebo matching Quetiapine XR.59140OG000

Outcome

Type
SECONDARY
Title
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)
Description
Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12
Time frame
After 8 week of start of treatment
Population
Full Analysis Set

Source ClinicalTrials.gov

Trial

Title
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
NCT number
NCT01256177
Phases
PHASE3
Conditions
Bipolar Depression
Interventions
Quetiapine Fumarate (SEROQUEL) Extended Release, Placebo
Lead sponsor
AstraZeneca
Results first posted
2016-02-03

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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