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Comparison · NCT00612807-sae

Semi-weekly Medication Management vs Semi-weekly Medication Management + Weekly Marital Therapy: 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. Semi-weekly Medication Management vs Semi-weekly Medication Management + Weekly Marital Therapy: serious adverse events. Trial comparisons, record NCT00612807-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00612807-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 100.00000000000000001390.215wilson
Risk in group 200.00000000000000001390.121wilson
Risk difference, group 1 minus group 20-0.1210.215newcombe 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

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Semi-weekly Medication ManagementMedication management with a study doctor every other week.014EG000
Group 2Semi-weekly Medication Management + Weekly Marital TherapyMedication management with a study doctor every other week plus weekly marital therapy.028EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Treatment of Mood and Marriage Study (TOMMS)
NCT number
NCT00612807
Phases
PHASE1, PHASE2
Conditions
Major Depressive Disorder, Partner Relational Disorder (V61.10)
Interventions
Weekly marital therapy, As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Lead sponsor
Duke University
Results first posted
2011-04-26

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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