Comparison · NCT00531518-sae
Family-aided Assertive Community Treatment vs Control Group: 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. Family-aided Assertive Community Treatment vs Control Group: serious adverse events. Trial comparisons, record NCT00531518-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00531518-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 | 0 | 0.0184 | wilson | |
| Risk in group 2 | 0.0115 | 0.00203 | 0.0623 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0115 | -0.0623 | 0.00919 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Family-aided Assertive Community Treatment than on Control Group | 87 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Family-aided Assertive Community Treatment | This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals. | 0 | 205 | EG001 |
| Group 2 | Control Group | This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff. | 1 | 87 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Over 24 months
Source ClinicalTrials.gov
Trial
- Title
- Early Detection and Intervention for the Prevention of Psychosis
- NCT number
- NCT00531518
- Phases
- NA
- Conditions
- Schizophrenia, Bipolar Disorder, Depression, Psychotic Disorders
- Interventions
- aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine, Psychoeducational multifamily group treatment, Supported employment and education
- Lead sponsor
- MaineHealth
- Results first posted
- 2016-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00531518?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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