Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy

NCT ID: NCT01942785

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31

Brief Summary

To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.

Conditions

Major Depressive Disorder; Irritability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brexpiprazole

Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)

Group Type: EXPERIMENTAL

Brexpiprazole

Intervention Type: DRUG

2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.

Interventions

Brexpiprazole

2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Main selection criteria at screening visit:

• The patient has a Major Depressive Episode (MDE) associated to Major Depressive Disorder (MDD) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
• The patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current MDE, as documented by self-report as less than a pre-defined percentage response on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ).
• Pre-defined MADRS total score
• Pre-defined CGI-S total score
• The patient has had the current MDE for ≥10 weeks
• The patient is receiving a SSRI or SNRI antidepressant treatment for ≥6 weeks, at same dosage for ≥2 weeks
• Pre-defined Inventory of Depressive Symptomatology - Clinician-Rated - 30 items (IDS-C 30) Item 6 Mood (irritable) score

• The patient still fulfils DSM-IV-TR™ criteria for MDE
• Pre-defined MADRS total score
• Pre-defined CGI-I (Lead-in period) score
• The patient received the same SSRI or SNRI antidepressant treatment at adequate doses during the entire lead-in period
• The patient has less than a pre-defined percentage decrease in MADRS score at the end of the lead-in period as compared to the screening visit
• The patient still has the pre-defined IDS-C 30 Item 6 Mood (Irritable) score

Exclusion Criteria

• The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the principal diagnosis, other than MDD. All anxiety disorders, impulse-control disorders such as intermittent explosive disorder, as well as non-suicidal self-injury are not excluded diagnoses as far as they are not considered as principal diagnosis.
• The patient has a current Axis II (DSM-IV-TR™) diagnosis of antisocial, borderline, paranoid, schizoid, schizotypical, or histrionic personality disorder.
• The patient has experienced/experiences hallucinations, delusions, or any psychotic symptomatology in the current MDE.
• The patient, in the opinion of the investigator or based on C-SSRS rating, is at significant risk of suicide.
• The patient has started formal cognitive or behavioural therapy or systematic psychotherapy within 6 weeks prior to screening, or plans to start such therapy during the study. Any ongoing formal psychotherapy initiated more than 6 weeks prior to screening should be continued with the same methodology and at the same frequency and intensity during the entire study.
• The patient has a current diagnosis or history of substance abuse or dependence (excluding nicotine or caffeine) or alcohol abuse or dependence (DSM-IV-TR™ criteria) <6 months prior to the Screening Visit.
• The patient reports adjunctive treatment with an antipsychotic medication together with an antidepressant for 3 weeks or more during the current MDE.
• The patient has received electroconvulsive therapy (ECT) <6 months prior to the Screening Visit or at any time during the current MDE (if its duration is longer than 6 months).
• The patient has had vagus nerve stimulation or a deep brain stimulation device implanted for the management of depression.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

US015

Tucson, Arizona, United States

US019

Glendale, California, United States

US016

Oakland, California, United States

US014

San Diego, California, United States

US011

Denver, Colorado, United States

US018

Hallandale, Florida, United States

US009

Jacksonville, Florida, United States

US005

Orlando, Florida, United States

US006

Gaithersburg, Maryland, United States

US012

Weymouth, Massachusetts, United States

US003

Jamaica, New York, United States

US001

Dayton, Ohio, United States

US007

Portland, Oregon, United States

US004

Memphis, Tennessee, United States

US002

Seattle, Washington, United States

Countries

United States

References

Fava M, Menard F, Davidsen CK, Baker RA. Adjunctive Brexpiprazole in Patients With Major Depressive Disorder and Irritability: An Exploratory Study. J Clin Psychiatry. 2016 Dec;77(12):1695-1701. doi: 10.4088/JCP.15m10470.

Reference Type: DERIVED

PMID: 27379823 (View on PubMed)

Other Identifiers

15353A

Identifier Type: -

Identifier Source: org_study_id