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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT01838681

Run by

H. Lundbeck A/S

People needed

1986

Starts

2013-06-01

Expected to finish

2016-06-01

Last updated by the study team

2017-08-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• US043 — Cerritos, California, United States
• US042 — Temecula, California, United States
• US053 — Flowood, Mississippi, United States
• US040 — Brooklyn, New York, United States
• US046 — Houston, Texas, United States
• US052 — Houston, Texas, United States
• US047 — Milwaukee, Wisconsin, United States
• BG007 — Kardzhali, Bulgaria
• BG002 — Pazardzhik, Bulgaria
• BG003 — Rousse, Bulgaria
• BG001 — Sofia, Bulgaria
• BG004 — Sofia, Bulgaria
• BG005 — Varna, Bulgaria
• BG006 — Varna, Bulgaria
• CA003 — Burlington, Canada
• CA004 — Edmonton, Alberta, Canada
• CA001 — Kingston, Canada
• CA002 — Montral, Canada
• CA005 — Montreal, Canada
• EE002 — Tallinn, Estonia
• EE003 — Tallinn, Estonia
• EE006 — Tallinn, Estonia
• EE001 — Tartu, Estonia
• EE005 — Tartu, Estonia
• US041 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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