Trial · NCT01727726
A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
NCT01727726, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2018-06-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial. Trials, record NCT01727726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01727726
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
- NCT number
- NCT01727726
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,182 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
- Interventions
- Brexpiprazole, Seroquel XR, Placebo
- First posted
- 2012-11-16
- Last updated
- 2018-06-08
- Results first posted
- 2018-06-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Montgomery Asberg Depression Rating Scale (MADRS) | Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16). | To determine the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy by assessment of MADRS total score. The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression. |
| Secondary | Sheehan Disability Scale (SDS) | Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16). | To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale is a measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains ( work/social life/family life/home responsibilities). The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. Scores of 5 and above are associated with significant functional impairment. Additionally, SDS included 2 questions related to productivity losses due to the psychiatric symptoms and impairment. |
| Secondary | Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4. | Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14) | Change from end of Phase A in MADRS Total Score. The MADRS was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression. |
| Secondary | Clinical Global Impression Score | From randomization to Phase B week 6 (14/16 weeks after randomization). | Mean change from end of Phase A in Clinical Global Impression - Severity of Illness scale (CGI-S) score and Improvement scale (CGI-I) during double-blind randomized Phase B treatment. CGI-S score assessed how mentally ill the patient was at that time. CGI-S score is calculated from 0 to 7 (0 indicates not assessed 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and7 indicated among the most extremely ill patient). CGI-I score is compared to his/her condition at baseline, how much has the patient changed. CGI-I score is calculated from 0 to 7 (0 indicates not assessed and 7 indicates very much worse). |
| Secondary | MADRS Response at Week 6 | Phase B week 6 (14/16 weeks after randomization). | MADRS Response Rate, where response was defined as 50% reduction in MADRS Total Score, during double-blind randomized Phase B treatment. |
| Secondary | Number of Participants With MADRS | Phase B week 6 (14/16 weeks after randomization). | MADRS Remission Rate, where remission was defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score, for every trial week visit during double-blind randomized Phase B treatment. |
| Secondary | CGI-I Response Rate | Phase B week 6 (14/16 weeks after randomization). | CGI-I Response rate, where response was defined as a CGI-I score of 1 or 2 (very much improved or much improved), during double-blind randomized Phase B treatment. |
| Secondary | Number of Participants With Adverse Events | From screening (Day -28 to Day-1) upto post treatment follow-up. | To evaluate the safety and tolerability of brexpiprazole (flexible dose) as adjunctive therapy to ADT in the proposed subject population with MDD as AE variables. |
| Secondary | Sheehan Disability Scale (SDS) Individual Item Scores. | Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16). | To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale (a self rated questionnaire) was used for measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains (work/school work, social life/leisure activities and family life/home responsibilities). All domains were rated on a score scale ranged from 0 (no impairment) to 10 (most severe). Score of 5 and above indicated significant functional impairment. A total score was addition of the 3 individual scores and the total score ranged from 0 (no impairment) to 30 (most severe). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Montgomery Asberg Depression Rating Scale (MADRS) | Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16). | All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sheehan Disability Scale (SDS) | Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16). | All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for SDS Score in Phase B. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4. | Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14) | All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression Score | From randomization to Phase B week 6 (14/16 weeks after randomization). | All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for CGI-S score and CGI-I score in Phase B. | Mean score | MEAN |
| SECONDARY | MADRS Response at Week 6 | Phase B week 6 (14/16 weeks after randomization). | All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With MADRS | Phase B week 6 (14/16 weeks after randomization). | Number of subjects in the Safety Sample who had an end of Phase A (ie, Week 8 or 10) value and at least one post randomization efficacy evaluation for MADRS Total Score in Phase B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | CGI-I Response Rate | Phase B week 6 (14/16 weeks after randomization). | All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | From screening (Day -28 to Day-1) upto post treatment follow-up. | Randomized subjects in Phase B who received at least one dose of double-blind trial medication as indicated on the dosing record. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sheehan Disability Scale (SDS) Individual Item Scores. | Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16). | All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | Brexpiprazole + ADT | -6.04 | Standard Error 0.43 | Units on a scale | |
| Montgomery Asberg Depression Rating Scale (MADRS) | Seroquel XR + ADT | -4.86 | Standard Error 0.57 | Units on a scale | |
| Montgomery Asberg Depression Rating Scale (MADRS) | Placebo + ADT | -4.57 | Standard Error 0.41 | Units on a scale | |
| Sheehan Disability Scale (SDS) | Brexpiprazole + ADT | -0.97 | Standard Error 0.12 | units on a scale | |
| Sheehan Disability Scale (SDS) | Seroquel XR + ADT | -0.32 | Standard Error 0.16 | units on a scale | |
| Sheehan Disability Scale (SDS) | Placebo + ADT | -0.74 | Standard Error 0.11 | units on a scale | |
| Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4. | Brexpiprazole + ADT | Phase B Week 2 | -2.57 | Standard Error 0.32 | units on a scale |
| Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4. | Seroquel XR + ADT | Phase B Week 2 | -2.26 | Standard Error 0.41 | units on a scale |
| Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4. | Placebo + ADT | Phase B Week 2 | -1.04 | Standard Error 0.31 | units on a scale |
| Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4. | Brexpiprazole + ADT | Phase B Week 4 | -4.39 | Standard Error 0.39 | units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brexpiprazole + ADT | 197 | |
| Overall Study | STARTED | Seroquel XR + ADT | 100 | |
| Overall Study | STARTED | Placebo + ADT | 206 | |
| Overall Study | COMPLETED | Brexpiprazole + ADT | 171 | |
| Overall Study | COMPLETED | Seroquel XR + ADT | 86 | |
| Overall Study | COMPLETED | Placebo + ADT | 186 | |
| Overall Study | NOT COMPLETED | Brexpiprazole + ADT | 26 | |
| Overall Study | NOT COMPLETED | Seroquel XR + ADT | 14 | |
| Overall Study | NOT COMPLETED | Placebo + ADT | 20 |
Source ClinicalTrials.gov
Adverse events42
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 | Asthenia | General disorders | Brexpiprazole + ADT | 4 | 197 | |
| other | Asthenia | General disorders | Seroquel XR + ADT | 2 | 100 | |
| other | Asthenia | General disorders | Placebo + ADT | 0 | 206 | |
| other | fatigue | General disorders | Brexpiprazole + ADT | 3 | 197 | |
| other | fatigue | General disorders | Seroquel XR + ADT | 4 | 100 | |
| other | fatigue | General disorders | Placebo + ADT | 3 | 206 | |
| other | Nasopharyngitis | Infections and infestations | Brexpiprazole + ADT | 9 | 197 | |
| other | Nasopharyngitis | Infections and infestations | Seroquel XR + ADT | 2 | 100 | |
| other | Nasopharyngitis | Infections and infestations | Placebo + ADT | 9 | 206 | |
| other | Weight Increased | Investigations | Brexpiprazole + ADT | 7 | 197 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brexpiprazole + ADT | 0 | 197 |
| Total, all-cause mortality | Seroquel XR + ADT | 0 | 100 |
| Total, all-cause mortality | Placebo + ADT | 0 | 206 |
| Total, other adverse events | Brexpiprazole + ADT | 62 | 197 |
| Total, other adverse events | Seroquel XR + ADT | 33 | 100 |
| Total, other adverse events | Placebo + ADT | 39 | 206 |
| Total, serious adverse events | Brexpiprazole + ADT | 0 | 197 |
| Total, serious adverse events | Seroquel XR + ADT | 1 | 100 |
| Total, serious adverse events | Placebo + ADT | 1 | 206 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01727726
GET https://conductscience.org/api/trials/v1/NCT01727726/results?page=2