Schizophrenia MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Brexpiprazole 1mg
Product Code: Lu AF41156, OPC-34712
Pharmaceutical Form: Tablet
INN or Proposed INN: Brexpiprazole
CAS Number: N/A
Current Sponsor code: Lu-AF41156
Other descriptive na
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 455 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Efficacy of brexpiprazole versus placebo on the treatment of acute schizophrenia;Secondary Objective: - Efficacy of brexpiprazole versus placebo on global clinical impression - Efficacy of brexpiprazole versus placebo on psychotic symptoms - Efficacy of brexpiprazole versus placebo on response rate - Efficacy of brexpiprazole versus placebo on personal and social performance ;Primary end point(s): Change from baseline in efficacy using PANSS;Timepoint(s) of evaluation of this end point: Baseline and Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change from baseline in clinical global impression -Improvement of clinical global impression -Change from baseline in psychotic symptoms (PANSS Positive Subscale score) -Change from baseline in psychotic symptoms (PANSS Negative Subscale score) Change from baseline in psychotic symptoms (PANSS Excited Component score) -Change from baseline in psychotic symptoms (PANSS Marder Factor scores) -Response rate -Change from baseline in personal and social performance -Safety and tolerability -Risk of suicidality;Timepoint(s) of evaluation of this end point: -Baseline and Week 6 -Week 6 -Baseline and Week 6 -Baseline and Week 6 -Baseline and Week 6 -Baseline and Week 6 -Baseline and Week 6 -Baseline and Week 6 -Up to 6 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) for patients who do not enter the follow-up study 14644B -Up to 6 weeks | — |
Countries
Bulgaria, Czech Republic, Estonia, France, Germany, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed