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Comparison · NCT01041274-sae

Citalopram 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. Citalopram vs Placebo: serious adverse events. Trial comparisons, record NCT01041274-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01041274-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 10.1020.04440.218wilson
Risk in group 20.0870.03430.203wilson
Risk difference, group 1 minus group 20.0151-0.1150.142newcombe hybrid score
Risk ratio, group 1 over group 21.170.3364.1log
Odds ratio, group 1 over group 21.190.34.75log
Number needed to harm, for one more participant with a serious adverse event on Citalopram than on Placebo66.3from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Citalopram
Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.~Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.
549EG000
Group 2Placebo
Participants will receive a daily dose of placebo for 12 months.~Placebo: Placebo by mouth daily for 12 months.~Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions~Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI~Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
446EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
DECIFER: Depression and Citalopram In First Episode Recovery
NCT number
NCT01041274
Phases
PHASE4
Conditions
Schizophrenia, Schizophreniform Disorder
Interventions
Citalopram, Placebo, Psychoeducation, Cognitive Behavioral Therapy (CBT), Functional Magnetic Resonance Imaging (fMRI)
Lead sponsor
NYU Langone Health
Results first posted
2018-11-16

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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