Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Phase 1

Conditions: 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 episode, mild degree System Organ Class: 100000004873
MedDRA version: 16.1 Level: LLT Classification code 10025458 Term: Major depressive disorder, recurrent episode, moderate degree System Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2012-001361-32-GB

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 129

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

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: - Efficacy of brexpiprazole versus placebo as adjunctive treatment to antidepressants on global clinical impression<br> - Efficacy of brexpiprazole versus placebo as adjunctive treatment to antidepressants on functioning<br> - Efficacy of brexpiprazole versus placebo as adjunctive treatment to antidepressants on social adaptation<br> ;<br> Primary end point(s): Change from randomisation in depressive symptoms during<br> the randomised treatment<br> ;Timepoint(s) of evaluation of this end point: Randomisation visit and end of randomisation treatment;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 Outcome Measures

Name	Time	Method

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