Major Depressive Disorder MedDRA version: 16.0 Level: LLT Classification code 10025461 Term: Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior System Organ Class: 100000004873 MedDRA version: 16.0 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode System Organ Class: 100000004873 MedDRA version: 16.0 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
INN or Proposed INN: Brexpiprazole
Current Sponsor code: Lu AF41156/ OPC- 34712
Concentration unit: mg milli
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator. • The patient had MDD at entry in lead-in brexpiprazole studies, 14570A or 14571A, diagnosed according to DSM-IV-TR™. • 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 554 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 630
Exclusion criteria
Exclusion criteria: • The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. • The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies 14570A or 14571A. • The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide. • The patient has any relevant medical history or current presence of systemic disease. • The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant. • The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator. • 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: To evaluate the long-term safety and tolerability of brexpiprazole as adjunct treatment to antidepressant (ADT);Secondary Objective: To evaluate the therapeutic effect of flexible dose brexpiprazole as adjunct treatment to ADT on depressive symptoms To evaluate the therapeutic effect of flexible dose brexpiprazole as adjunct treatment to ADT on clinical global impression To evaluate the therapeutic effect of flexible dose brexpiprazole as adjunct treatment to ADT on health-related quality of life;Primary end point(s): 1. Safety 2. Tolerability 3. Risk of suicidality;Timepoint(s) of evaluation of this end point: 1.Up to 52 weeks and a 4-week safety follow up 2. Up to 52 weeks 3. Up to 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in depressive symptoms 2. Proportion of patients in remission 3. Change in clinical global impression 4. Change in health-related quality of life (Q-LES-Q-(SF)) 5. Change in health-related quality of life (EQ-5D-5L);Timepoint(s) of evaluation of this end point: 1. Baseline and Week 52 2. Baseline and Week 52 3. Baseline and Week 52 4. Baseline and Week 52 5. Baseline and Week 52 | — |
Countries
Argentina, Australia, Bulgaria, Canada, Chile, Estonia, Finland, Germany, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, Slovakia, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed