Comparison · NCT00612313-sae
Continued Medication Alone vs Continued Medication Plus CBT: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Continued Medication Alone vs Continued Medication Plus CBT: serious adverse events. Trial comparisons, record NCT00612313-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00612313-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.101 | 0.05 | 0.195 | wilson | |
| Risk in group 2 | 0.12 | 0.0644 | 0.213 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0186 | -0.124 | 0.0902 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.845 | 0.333 | 2.15 | log | |
| Odds ratio, group 1 over group 2 | 0.828 | 0.291 | 2.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Continued Medication Alone than on Continued Medication Plus CBT | 53.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Continued Medication Alone | Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~N=69 | 7 | 69 | EG000 |
| Group 2 | Continued Medication Plus CBT | Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~N=75 | 9 | 75 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse
- NCT number
- NCT00612313
- Phases
- NA
- Conditions
- Depression
- Interventions
- Fluoxetine, Relapse prevention cognitive behavioral therapy (CBT)
- Lead sponsor
- University of Texas Southwestern Medical Center
- Results first posted
- 2014-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00612313?tab=results
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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