Phase 3
Completed N=503
A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
Source: ClinicalTrials.gov NCT01727726 ↗Enrolled (actual)
503
Serious AEs
0.4%
Results posted
Jun 2018
Primary outcomePrimary: Montgomery Asberg Depression Rating Scale (MADRS) — -6.04; -4.86; -4.57 Units on a scale — p=0.0078
◆ Published Evidence
Established
20citations · ~3 / year
Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale.
Summary
To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.
Linked Publications (2)
-
Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale.
-
Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) |
-6.04; -4.86; -4.57 | 0.0078 sig |
| SECONDARY Sheehan Disability Scale (SDS) |
-0.97; -0.32; -0.74 | 0.1334 |
| SECONDARY Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4. |
-2.57; -2.26; -1.04; -4.39; -3.30; -3.22 | 0.0001 sig |
| SECONDARY Clinical Global Impression Score |
3.98; 4.07; 4.02; 2.55; 2.71; 2.74 | 0.0350 sig |
| SECONDARY MADRS Response at Week 6 |
20; 8; 14 | 0.2242 |
| SECONDARY Number of Participants With MADRS |
13; 2; 9 | 0.3321 |
| SECONDARY CGI-I Response Rate |
100; 48; 79 | 0.0032 sig |
| SECONDARY Number of Participants With Adverse Events |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Sheehan Disability Scale (SDS) Individual Item Scores. |
-0.59; -0.22; -0.74; -1.03; -0.26; -0.70 | 0.4480 |
Eligibility Criteria
Inclusion Criteria
- Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
- Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.
Exclusion Criteria
- Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
- Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
- Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
- Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
- Subjects currently treated with insulin for diabetes.
- Subjects with uncontrolled hypertension
- Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
- Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
- Inability to swallow tablets or tolerate oral medication
- Abnormal laboratory test results, vital signs and ECG results
- Subjects who previously participated in any prior brexpiprazole clinical trial.
Data sourced from ClinicalTrials.gov (NCT01727726) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.