Phase 3
N=468
Brexpiprazole in Patients With Acute Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01810380 ↗Enrolled (actual)
468
Serious AEs
3.2%
Results posted
Mar 2016
Primary outcome: Primary: Change From Baseline to Week 6 in PANSS Total Score — -15.9; -20.0; -24.0 units on a scale — p=0.0560
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Brexpiprazole (Drug); Quetiapine extended release (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lundbeck A/S
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in PANSS Total Score |
-15.9; -20.0; -24.0 | 0.0560 |
| SECONDARY Change From Baseline to Week 6 in CGI-S Score |
-0.9; -1.2; -1.4 | — |
| SECONDARY CGI-I Score at Week 6 |
3.0; 2.7; 2.5 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Positive Subscale Score |
-5.4; -7.0; -8.1 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Negative Subscale Score |
-3.1; -3.7; -4.5 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score |
-8.2; -9.9; -11.6 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Excited Component Score |
-2.5; -3.3; -3.9 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms |
-3.6; -4.3; -4.8 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms |
-5.7; -7.1; -8.4 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts |
-3.2; -4.0; -4.8 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement |
-1.8; -2.5; -2.8 | — |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression |
-2.9; -3.2; -3.6 | — |
| SECONDARY Discontinuation Due to Lack of Efficacy During the Study |
14.91; 6.67; 7.19 | — |
| SECONDARY Response Rate at Week 6 |
32.1; 48.7; 62.7 | — |
| SECONDARY Change From Baseline to Week 6 in PSP Total Score |
9.4; 13.0; 15.3 | — |
| SECONDARY PSP Functional Remission Rate at Week 6 |
5.7; 9.6; 14.4 | — |
| SECONDARY PSP Functional Response Rate at Week 6 |
36.3; 53.4; 64.4 | — |
| SECONDARY PSP Domain D: Disturbing and Aggressive Behaviours at Week 6 |
30.4; 27.2; 22.2 | — |
Summary
To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.
Eligibility Criteria
Inclusion Criteria
- The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
- The patient is willing to be hospitalised from the Screening Visit through Week 6.
- The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
- The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
- The patient agrees to protocol-defined use of effective contraception.
Exclusion Criteria
- The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
- The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
- The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
- The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
- The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
- The patient has a history of neuroleptic malignant syndrome.
- The patient has any relevant medical history or current presence of systemic disease.
- The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
- The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of brexpiprazole.
- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01810380). 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.