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Clinical Trials/NCT01837797
NCT01837797TerminatedPhase 3

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study to Evaluate the Efficacy and Safety of Brexpiprazole (1 and 3 mg/Day) as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

H. Lundbeck A/S2 sites in 1 country129 target enrollmentStarted: April 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
129
Locations
2
Primary Endpoint
Change From Randomisation in Depressive Symptoms During the Randomised Treatment
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

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 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.

Arms & Interventions

Placebo

Placebo Comparator

Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)

Intervention: Placebo (Drug)

Brexpiprazole 1 mg

Experimental

Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week followed by 1 mg/day.

Intervention: Brexpiprazole 1 mg (Drug)

Brexpiprazole 3 mg

Experimental

Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week, 1 mg/day in the second week, followed by 3 mg/day.

Intervention: Brexpiprazole 3 mg (Drug)

Outcomes

Primary Outcomes

Change From Randomisation in Depressive Symptoms During the Randomised Treatment

Time Frame: From randomisation to end of treatment (week 20)

Montgomery and Aasberg Depression Rating Scale (MADRS) total score

Secondary Outcomes

  • Number of Adverse Events(From randomisation to follow-up (week 24))
  • Change From Randomisation in Clinical Global Impression During the Randomised Treatment(From randomisation to end of treatment (week 20))
  • Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment(From randomisation to end of treatment (week 20))
  • Change From Randomisation in Social Adaptation During the Randomised Treatment(From randomisation to end of treatment (week 20))
  • Response During the Randomised Treatment(From randomisation to end of treatment (week 20))
  • Sustained Response During the Randomised Treatment(From randomisation to end of treatment (week 20))
  • Remission During the Randomised Treatment(From randomisation to end of treatment (week 20))
  • Sustained Remission During the Randomised Treatment(From randomisation to end of treatment (week 20))
  • Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)(From randomisation to end of treatment (week 20))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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