Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Phase 1

Conditions: Major Depressive Disorder
MedDRA version: 18.0Level: LLTClassification code 10025461Term: Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behaviorSystem Organ Class: 100000004873
MedDRA version: 18.0Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873
MedDRA version: 18.0Level: LLTClassification code 10025469Term: Major depressive disorder, single episode, severe degree, without mention of psychotic behaviorSystem Organ Class: 100000004873
MedDRA version: 18.0Level: LLTClassification code 10025462Term: Major depressive disorder, recurrent episode, unspecified degreeSystem Organ Class: 100000004873
MedDRA version: 18.0Level: LLTClassification code 10025467Term: Major depressive disorder, single episode, moderate degreeSystem Organ Class: 100000004873
MedDRA version: 18.0Level: LLTClassification code 10025458Term: Major depressive disorder, recurrent episode, moderate degreeSystem Organ Class: 100000004873
MedDRA version: 18.0Level: LLTClassification code 10025470Term: Major depressive disorder, single episode, unspecified degreeSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2012-001380-76-LT

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2924

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

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.