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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01837797
• Other study ID #: 14571A
• Secondary ID: 2012-001361-32
• Status: Terminated
• Phase: Phase 3
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 129
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Once daily, tablets, orally
• Brexpiprazole 1 mg
once daily dose, tablets, orally
• Brexpiprazole 3 mg
once daily dose, tablets, orally

Locations

Country	Name	City	State
United States	US001	National City	California
United States	US008	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Randomisation in Depressive Symptoms During the Randomised Treatment	Montgomery and Aasberg Depression Rating Scale (MADRS) total score	From randomisation to end of treatment (week 20)
Secondary	Number of Adverse Events	15 patients were enrolled to Period 2; only 3 patients completed due to study termination	From randomisation to follow-up (week 24)
Secondary	Change From Randomisation in Clinical Global Impression During the Randomised Treatment	Clinical Global Impression - Severity of illness (CGI-S) score	From randomisation to end of treatment (week 20)
Secondary	Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment	Sheehan Disability Scale (SDS) total score	From randomisation to end of treatment (week 20)
Secondary	Change From Randomisation in Social Adaptation During the Randomised Treatment	Social Adaptation Self-evaluation Scale (SASS) total score	From randomisation to end of treatment (week 20)
Secondary	Response During the Randomised Treatment	Based on a pre-specified decrease in MADRS total score	From randomisation to end of treatment (week 20)
Secondary	Sustained Response During the Randomised Treatment	Based on a pre-specified decrease in MADRS total score	From randomisation to end of treatment (week 20)
Secondary	Remission During the Randomised Treatment	Based on a pre-specified MADRS total score	From randomisation to end of treatment (week 20)
Secondary	Sustained Remission During the Randomised Treatment	Based on a pre-specified MADRS total score	From randomisation to end of treatment (week 20)
Secondary	Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)	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.	From randomisation to end of treatment (week 20)

External Links

•   EMA EudraCT Result Posting