Trial · NCT01838681
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
NCT01838681, Phase 3, Completed, H. Lundbeck A/S; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment. Trials, record NCT01838681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01838681
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
- NCT number
- NCT01838681
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,986 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Major Depressive Disorder
- Interventions
- Placebo, Brexpiprazole, ADT
- First posted
- 2013-04-24
- Last updated
- 2017-08-09
- Other registries' IDs
- eudract:2012-001380-76
- Results first posted
- 2017-08-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Full Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items. |
| Secondary | Full Functional Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | 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. |
| Secondary | Full Global Score Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Full global score remission is defined as a Clinical Global Impression - Severity of Illness (CGI-S) score \<=2 observed for at least 8 consecutive weeks during the randomised treatment period. The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis, on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Secondary | Total Time in Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The total time the patient spends in remission during randomised treatment. Remission is defined as a MADRS total score \<=10 and a \>=50% decrease from randomisation in MADRS total score. Time in remission is defined as the sum of days over all periods between Period B visits where remission was obtained. The period between two visits is counted as in remission if the patient was in remission when the period started. |
| Secondary | Time to Full Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The time from randomisation until full remission has been obtained. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. The time to full remission was calculated using Kaplan-Meier Methods. |
| Secondary | Full Remission Sustained During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Full remission sustained is defined as having obtained full remission and remain in remission until completion of the study. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. |
| Secondary | Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period | From randomisation to week 6 | The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items. |
| Secondary | Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items. |
| Secondary | Response at Week 6 During the Randomised Treatment Period | From randomisation to week 6 | Response is defined as a \>=50% decrease from randomisation in MADRS total score. |
| Secondary | Response at Week 24 During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Response is defined as a \>=50% decrease from randomisation in MADRS total score. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Full Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | participants | NUMBER |
| SECONDARY | Full Functional Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | participants | NUMBER |
| SECONDARY | Full Global Score Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | participants | NUMBER |
| SECONDARY | Total Time in Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | Number of days | MEAN |
| SECONDARY | Time to Full Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | Days | MEDIAN |
| SECONDARY | Full Remission Sustained During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | participants | NUMBER |
| SECONDARY | Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period | From randomisation to week 6 | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Response at Week 6 During the Randomised Treatment Period | From randomisation to week 6 | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF). | participants | NUMBER |
| SECONDARY | Response at Week 24 During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF). | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Full Remission During the Randomised Treatment Period | Period B Placebo and ADT (24 Weeks Randomised Treatment) | 110 | participants | ||
| Full Remission During the Randomised Treatment Period | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | 95 | participants | ||
| Full Functional Remission During the Randomised Treatment Period | Period B Placebo and ADT (24 Weeks Randomised Treatment) | 73 | participants | ||
| Full Functional Remission During the Randomised Treatment Period | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | 68 | participants | ||
| Full Global Score Remission During the Randomised Treatment Period | Period B Placebo and ADT (24 Weeks Randomised Treatment) | 143 | participants | ||
| Full Global Score Remission During the Randomised Treatment Period | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | 121 | participants | ||
| Total Time in Remission During the Randomised Treatment Period | Period B Placebo and ADT (24 Weeks Randomised Treatment) | 33.5 | Standard Deviation 46.1 | Number of days | |
| Total Time in Remission During the Randomised Treatment Period | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | 30.0 | Standard Deviation 44.3 | Number of days | |
| Time to Full Remission During the Randomised Treatment Period | Period B Placebo and ADT (24 Weeks Randomised Treatment) | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Full Remission During the Randomised Treatment Period | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | NA | 95% Confidence Interval NA to NA | Days |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period A | STARTED | Period A Placebo and ADT (8 Weeks) | 1,986 | |
| Period A | STARTED | Period B Placebo and ADT (24 Weeks Randomised Treatment) | 0 | |
| Period A | STARTED | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | 0 | |
| Period A | STARTED | Period A+ Placebo and ADT (Non-randomised Patients) | 0 | |
| Period A | COMPLETED | Period A Placebo and ADT (8 Weeks) | 1,661 | |
| Period A | COMPLETED | Period B Placebo and ADT (24 Weeks Randomised Treatment) | 0 | |
| Period A | COMPLETED | Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) | 0 | |
| Period A | COMPLETED | Period A+ Placebo and ADT (Non-randomised Patients) | 0 | |
| Period A | NOT COMPLETED | Period A Placebo and ADT (8 Weeks) | 325 | |
| Period A | NOT COMPLETED | Period B Placebo and ADT (24 Weeks Randomised Treatment) | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo and ADT | 34 | 441 | |
| other | Nasopharyngitis | Infections and infestations | Brexpiprazole and ADT | 28 | 444 | |
| other | Accidental overdose | Injury, poisoning and procedural complications | Placebo and ADT | 25 | 441 | |
| other | Accidental overdose | Injury, poisoning and procedural complications | Brexpiprazole and ADT | 27 | 444 | |
| other | Weight increased | Investigations | Placebo and ADT | 22 | 441 | |
| other | Weight increased | Investigations | Brexpiprazole and ADT | 42 | 444 | |
| other | Headache | Nervous system disorders | Placebo and ADT | 31 | 441 | |
| other | Headache | Nervous system disorders | Brexpiprazole and ADT | 34 | 444 | |
| serious | Pancreatitis | Gastrointestinal disorders | Placebo and ADT | 0 | 441 | |
| serious | Pancreatitis | Gastrointestinal disorders | Brexpiprazole and ADT | 1 | 444 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo and ADT | ||
| Total, all-cause mortality | Brexpiprazole and ADT | ||
| Total, other adverse events | Placebo and ADT | 97 | 441 |
| Total, other adverse events | Brexpiprazole and ADT | 108 | 444 |
| Total, serious adverse events | Placebo and ADT | 13 | 441 |
| Total, serious adverse events | Brexpiprazole and ADT | 9 | 444 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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 |
| Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Full Remission Sustained During the Randomised Treatment Period | Trial comparisons |
| Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Response at Week 6 During the Randomised Treatment Period | Trial comparisons |
| Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Remission at Week 24 in the Randomised Treatment Period | Trial comparisons |
| Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Remission at Week 6 During the Randomised Treatment Period | Trial comparisons |
| Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Full Global Score Remission During the Randomised Treatment Period | Trial comparisons |
| Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Full Remission During the Randomised Treatment Period | Trial comparisons |
| Period B Placebo and ADT (24 Weeks Randomised Treatment) vs Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment): Response at Week 24 During the Randomised Treatment Period | Trial comparisons |
| Placebo and ADT vs Brexpiprazole and ADT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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