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

NCT01837797 | Terminated Phase 3 Results

• 2 other identifiers: 14571A2012-001361-32
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Drug: Brexpiprazole 1 mg

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.

Drug: Brexpiprazole 3 mg

Interventions

Placebo DRUG

Once daily, tablets, orally

Placebo

Brexpiprazole 1 mg DRUG

once daily dose, tablets, orally

Brexpiprazole 1 mg

Brexpiprazole 3 mg DRUG

once daily dose, tablets, orally

Brexpiprazole 3 mg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

US001

National City, California, 91950, United States

Location

US008

Orlando, Florida, 32806, United States

Location

Related Links

• EMA EudraCT Result Posting

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

Because the study was terminated, few efficacy data were collected. These data have not been reported in accordance with the ICH E3 regarding abbreviated clinical study reports. Furthermore, no firm conclusions can be drawn regarding safety.

Results Point of Contact

• Title: Email contact via H. Lundbeck A/S
• Organization: Study Director

LundbeckClinicalTrials@lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 17, 2018
• Results First Posted: March 3, 2016

Record last verified: 2018-09

Locations

US (2)