Status:
COMPLETED
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Lead Sponsor:
H. Lundbeck A/S
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
Detailed Description
The total duration of the study was 32 weeks and the study consisted of Periods A, B, and A+. Patients entered the study in Period A and were treated open-label with one of six commercially available ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 current presence of systemic disease.
- 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.
- Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
1986 Patients enrolled
Trial Details
Trial ID
NCT01838681
Start Date
June 1 2013
End Date
June 1 2016
Last Update
August 9 2017
Active Locations (107)
Enter a location and click search to find clinical trials sorted by distance.
1
US041
Little Rock, Arkansas, United States
2
US043
Cerritos, California, United States
3
US042
Temecula, California, United States
4
US053
Flowood, Mississippi, United States