Major Depressive Disorder MedDRA version: 16.1 Level: LLT Classification code 10025461 Term: Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior System Organ Class: 100000004873 MedDRA version: 16.1 Level: LLT Classification code 10025462 Term: Major depressive disorder, recurrent episode, unspecified degree System Organ Class: 100000004873 MedDRA version: 16.1 Level: LLT Classification code 10025457 Term: Major depressive disorder, recurrent epi
Conditions
Interventions
Product Name: Brexpiprazole
Product Code: Lu AF41156/OPC-34712
Pharmaceutical Form: Tablet
Current Sponsor code: Lu AF41156/ OPC- 34712
Other descriptive name: brexpiprazole
Concentration unit: mg mil
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •The patient is an outpatient consulting a psychiatrist. •The patient has a recurrent Major Depressive Disorder diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI). •The patient had at least one previous MDE before the age of 60 years. •The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments. •The patient, if a woman, must have had her last natural menstruation =24 months prior to the Screening Visit. •The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1922
Exclusion criteria
Exclusion criteria: •The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD. •The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder. •The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE. •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 had neuroleptic malignant syndrome. •The patient has any relevant medical history or currrent presence of systemic disease. •The patient has a neurodegenerative disorder. •The patient has, at the Screening Visit an abnormal ECG that is, 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 IMP. •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 on depressive symptoms of brexpiprazole versus placebo as adjunctive treatment to antidepressants in elderly patients with an inadequate response to antidepressant treatment;Secondary Objective: - Efficacy of brexpiprazole versus placebo as adjunctive treatment to antidepressants on global clinical impression - Efficacy of brexpiprazole versus placebo as adjunctive treatment to antidepressants on functioning - Efficacy of brexpiprazole versus placebo as adjunctive treatment to antidepressants on social adaptation;Primary end point(s): Change from randomisation in depressive symptoms during the randomised treatment;Timepoint(s) of evaluation of this end point: Randomisation visit and end of randomisation treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Change from randomisation in global clinical impression during the randomised treatment 2.Change from randomisation in functionality assessed by SDS during the randomised treatment 3.Change from randomisation in social adaptation during the randomised treatment 4.Response during the randomised treatment 5.Sustained response during the randomised treatment 6.Remission during the randomised treatment 7.Sustained remission during the randomised treatment 8.Safety and tolerability 9.Risk of suicidality;Timepoint(s) of evaluation of this end point: 1.Randomisation visit and end of randomisation treatment 2.Randomisation visit and end of randomisation treatment 3.Randomisation visit and end of randomisation treatment 4.Randomisation visit and end of randomisation treatment 5.2 weeks after randomisation visit to end of randomized Treatment 6.Randomisation visit and end of randomisation treatment 7.2 weeks after randomisation visit to end of randomized Treatment 8.Up to 20 weeks and a 4-week safety follow up 9.Up to 20 weeks | — |
Countries
Argentina, Bulgaria, Chile, China, Czech Republic, Estonia, Finland, Germany, Korea, Republic of, Lithuania, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed