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Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT01837797
Recruitment Status : Terminated (The study was terminated because of recruitment challenges)
First Posted : April 23, 2013
Results First Posted : March 3, 2016
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE April 4, 2013
First Posted Date  ICMJE April 23, 2013
Results First Submitted Date  ICMJE August 17, 2015
Results First Posted Date  ICMJE March 3, 2016
Last Update Posted Date October 17, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
Change From Randomisation in Depressive Symptoms During the Randomised Treatment [ Time Frame: Up to 20 weeks ]
Montgomery Åsberg Depression Rating Scale (MADRS) total score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • Number of Adverse Events [ Time Frame: From randomisation to follow-up (week 24) ]
    15 patients were enrolled to Period 2; only 3 patients completed due to study termination
  • Change From Randomisation in Clinical Global Impression During the Randomised Treatment [ Time Frame: From randomisation to end of treatment (week 20) ]
    Clinical Global Impression - Severity of illness (CGI-S) score
  • Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment [ Time Frame: From randomisation to end of treatment (week 20) ]
    Sheehan Disability Scale (SDS) total score
  • Change From Randomisation in Social Adaptation During the Randomised Treatment [ Time Frame: From randomisation to end of treatment (week 20) ]
    Social Adaptation Self-evaluation Scale (SASS) total score
  • Response During the Randomised Treatment [ Time Frame: From randomisation to end of treatment (week 20) ]
    Based on a pre-specified decrease in MADRS total score
  • Sustained Response During the Randomised Treatment [ Time Frame: From randomisation to end of treatment (week 20) ]
    Based on a pre-specified decrease in MADRS total score
  • Remission During the Randomised Treatment [ Time Frame: From randomisation to end of treatment (week 20) ]
    Based on a pre-specified MADRS total score
  • Sustained Remission During the Randomised Treatment [ Time Frame: From randomisation to end of treatment (week 20) ]
    Based on a pre-specified MADRS total score
  • Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) [ Time Frame: From randomisation to end of treatment (week 20) ]
    The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
  • Change from randomisation in global clinical impression during the randomised treatment [ Time Frame: Up to 20 weeks ]
    Clinical Global Impression - Severity of illness (CGI-S) score
  • Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment [ Time Frame: Up to 20 weeks ]
    Sheehan Disability Scale (SDS) total score
  • Change From Randomisation in Social Adaptation During the Randomised Treatment [ Time Frame: Up to 20 weeks ]
    Social Adaptation Self-evaluation Scale (SASS) total score
  • Response During the Randomised Treatment [ Time Frame: Up to 20 weeks ]
    Based on pre-specified decrease in MADRS total score
  • Sustained Response During the Randomised Treatment [ Time Frame: Up to 20 weeks ]
    Based on pre-specified decrease in MADRS total score
  • Remission During the Randomised Treatment [ Time Frame: Up to 20 weeks ]
    Based on a pre-specified MADRS total score
  • Sustained Remission During the Randomised Treatment [ Time Frame: Up to 20 weeks ]
    Based on pre-specified MADRS total score
  • Safety and tolerability [ Time Frame: Up to 20 weeks and a 4-week safety follow up ]
    Number of adverse events
  • Risk of suicidality [ Time Frame: Up to 20 weeks ]
    Columbia Suicide Severity Rating Scale (eC-SSRS) score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Official Title  ICMJE 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
Brief Summary To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Placebo
    Once daily, tablets, orally
  • Drug: Brexpiprazole 1 mg
    once daily dose, tablets, orally
  • Drug: Brexpiprazole 3 mg
    once daily dose, tablets, orally
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
    Intervention: Drug: Placebo
  • Experimental: Brexpiprazole 1 mg
    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: Drug: Brexpiprazole 1 mg
  • Experimental: Brexpiprazole 3 mg
    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: Drug: Brexpiprazole 3 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 4, 2014)
129
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2013)
1334
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837797
Other Study ID Numbers  ICMJE 14571A
2012-001361-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP