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Status:

TERMINATED

Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly 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

65+ years

Phase:

PHASE3

Brief Summary

To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)

Eligibility Criteria

Inclusion

  • 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.

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 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.
  • Other inclusion and exclusion criteria may apply.

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2014

Estimated Enrollment :

129 Patients enrolled

Trial Details

Trial ID

NCT01837797

Start Date

April 1 2013

End Date

May 1 2014

Last Update

October 17 2018

Active Locations (2)

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Page 1 of 1 (2 locations)

1

US001

National City, California, United States, 91950

2

US008

Orlando, Florida, United States, 32806