Comparison · NCT01838681-06e50dc3
Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Full Functional Remission During the Randomised Treatment Period
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. Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Full Functional Remission During the Randomised Treatment Period. Trial comparisons, record NCT01838681-06e50dc3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01838681-06e50dc3
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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 | 0.166 | 0.134 | 0.203 | wilson | |
| Risk in group 2 | 0.153 | 0.123 | 0.19 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0124 | -0.036 | 0.0608 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.798 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.765 | 1.57 | log | |
| Number needed to treat, for one more participant with the outcome on Period B Placebo and ADT (24 Weeks Randomised Treatment) than on Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | 80.8 | 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 | Period B Placebo and ADT (24 Weeks Randomised Treatment) | Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally | 73 | 441 | OG000 |
| Group 2 | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally | 68 | 444 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Full Functional Remission During the Randomised Treatment Period
- Description
Full functional remission is defined as a Sheehan Disability Scale (SDS) total score \<=6 and all SDS domain scores \<=2 observed for at least 8 consecutive weeks during the randomised treatment period. The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
- Time frame
- From randomisation to end of Period B (24 weeks)
- Population
- All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Source ClinicalTrials.gov
Trial
- Title
- Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
- NCT number
- NCT01838681
- Phases
- PHASE3
- Conditions
- Major Depressive Disorder
- Interventions
- Placebo, Brexpiprazole, ADT
- Lead sponsor
- H. Lundbeck A/S
- Results first posted
- 2017-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01838681?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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