Major Depressive Disorder MedDRA version: 18.0 Level: LLT Classification code 10025461 Term: Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior System Organ Class: 100000004873 MedDRA version: 18.0 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode System Organ Class: 100000004873 MedDRA version: 18.0 Level: LLT Classification code 10025469 Term: Major depressive disorder, single episode, severe degree, witho
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 mi
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •The patient is an outpatient consulting a psychiatrist. •The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI). •The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments. •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 2632 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 292
Exclusion criteria
Exclusion criteria: 1.The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD. 2.The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder. 3.The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE. 4.The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria). 5.The patient, in the opinion of the investigator or according to Columbia- Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide. 6.The patient has had neuroleptic malignant syndrome. 7.The patient has any relevant medical history or current presence of systemic disease. 8.The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant. 9.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. 10.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 during long-term treatment with brexpiprazole versus placebo as adjunctive treatment to antidepressants in patients with an inadequate response to antidepressant treatment;Secondary Objective: - Efficacy of brexpiprazole versus placebo during long-term adjunctive treatment on functionality - Efficacy of brexpiprazole versus placebo during long-term adjunctive treatment on clinical global impression - Efficacy of brexpiprazole versus placebo during long-term adjunctive treatment on health-related quality of life ;Primary end point(s): Full remission during the randomised treatment period;Timepoint(s) of evaluation of this end point: Randomisation to week 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Full functional remission during the randomised treatment 2.Full global score remission in global clinical impression during the randomised treatment 3.Change from randomisation in depressive symptoms during the randomised treatment 4.Response during the randomised treatment 5.Remission during the randomised treatment 6.Total time in remission during the randomised treatment 7.Time to full remission during the randomised treatment 8.Change from randomisation in clinical global impression during the randomised treatment 9.Change from randomisation in functionality 10.Change from randomisation in health-related quality of life 11.Safety and tolerability 12.Risk of suicidality ;Timepoint(s) of evaluation of this end point: 1.Randomisation to week 32 2. Randomisation to week 32 3. Randomisation to week 32 4. Randomisation to week 32 5. Randomisation to week 32 6. Randomisation to week 32 7. Randomisation to week 32 8. Randomisation to week 32 9. Randomisation to week 32 10. Randomisation to week 32 11.Up to 32 weeks and a 4-week safety follow up 12.Up to 32 weeks | — |
Countries
Bulgaria, Canada, Estonia, Finland, Germany, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed