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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 : March 3, 2016
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: Brexpiprazole 1 mg Drug: Brexpiprazole 3 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2013
Actual Primary Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Drug: Placebo
Once daily, tablets, orally

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.
Drug: Brexpiprazole 1 mg
once daily dose, tablets, orally

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.
Drug: Brexpiprazole 3 mg
once daily dose, tablets, orally




Primary Outcome Measures :
  1. Change From Randomisation in Depressive Symptoms During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Montgomery and Aasberg Depression Rating Scale (MADRS) total score


Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: From randomisation to follow-up ]
    15 patients were enrolled to Period 2; only 3 patients completed due to study termination

  2. Change From Randomisation in Clinical Global Impression During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Clinical Global Impression - Severity of illness (CGI-S) score

  3. Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Sheehan Disability Scale (SDS) total score

  4. Change From Randomisation in Social Adaptation During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Social Adaptation Self-evaluation Scale (SASS) total score

  5. Response During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Based on a pre-specified decrease in MADRS total score

  6. Sustained Response During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Based on a pre-specified decrease in MADRS total score

  7. Remission During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Based on a pre-specified MADRS total score

  8. Sustained Remission During the Randomised Treatment [ Time Frame: From randomisation to end of treatment ]
    Based on a pre-specified MADRS total score

  9. 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 ]
    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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837797


Locations
United States, California
US001
National City, California, United States, 91950
United States, Florida
US008
Orlando, Florida, United States, 32806
Sponsors and Collaborators
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Additional Information:
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01837797     History of Changes
Other Study ID Numbers: 14571A
2012-001361-32 ( EudraCT Number )
First Posted: April 23, 2013    Key Record Dates
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Brexpiprazole
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents