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Comparison · NCT00709202-sae

Betahistine vs Placebo: serious adverse events

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. Betahistine vs Placebo: serious adverse events. Trial comparisons, record NCT00709202-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00709202-sae

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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 1000.168wilson
Risk in group 2000.161wilson
Risk difference, group 1 minus group 20-0.1610.168newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1BetahistineSubjects assigned to this arm will receive Betahistine.~Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.019EG000
Group 2PlaceboSubjects in this group will received placebo.~Placebo Oral Tablet020EG001

Harm

What it counts
Total, serious adverse events
Time frame
12 weeks during study drug administration

Source ClinicalTrials.gov

Trial

Title
Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
NCT number
NCT00709202
Phases
PHASE2
Conditions
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar I Disorder, Bipolar II, Bipolar NOS(Not Otherwise Specified), Psychotic Disorder Not Otherwise Specified, Autism Spectrum Disorder
Interventions
Betahistine, Placebo Oral Tablet
Lead sponsor
Nathan Kline Institute for Psychiatric Research
Results first posted
2019-01-25

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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