Phase 3 N=54 Treatment

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

Major Depressive Disorder · Irritability

Bottom Line

View on ClinicalTrials.gov: NCT01942785 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Change From Baseline to Week 6 in SIS Total Score — -21.13 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Brexpiprazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: H. Lundbeck A/S
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 6 in SIS Total Score	-21.13	—
PRIMARY Change From Baseline to Week 6 in SIS Item 1 Score	-3.45	—
PRIMARY Change From Baseline to Week 6 in IDS-C30 Item 6 Score	-1.22	—
PRIMARY Change From Baseline to Week 6 in Delay Discounting - Log-transformed MCQ Scores	0.00	—
PRIMARY Change From Baseline to Week 6 in BIS-11 Total Score	-4.85	—
PRIMARY Change From Baseline to Week 6 in KSQ Anger-hostility Subscore	-7.72	—
PRIMARY Shift From Baseline to Week 6 in Anger Attacks (AAQ)	28; 5; 15; 2	—
PRIMARY Change From Baseline to Week 6 in IDS-C30 Total Score	-17.81	—
PRIMARY Change From Baseline to Week 6 in KSQ Depression Subscore	-7.70	—
PRIMARY Change From Baseline to Week 6 in MADRS Total Score	-14.19	—
PRIMARY Change From Baseline to Week 6 in CPFQ Total Score	-7.72	—
PRIMARY Change From Baseline to Week 6 in CGI-S Score	-1.43	—
PRIMARY CGI-I Score at Week 6	2.18	—
PRIMARY Change From Baseline to Week 6 in KSQ Total Score	-24.36	—
PRIMARY Change From Baseline to Week 6 in Delay Discounting - Log-transformed EDT DPDT Scores	-0.223; -0.295	—
PRIMARY Change From Baseline to Week 6 in Delay Discounting - EDT DRT Score	0.74	—
PRIMARY Change From Week 6 to Week 10 in SIS Total Score	4.4	—
PRIMARY Change From Week 6 to Week 10 in SIS Item 1 Score	0.5	—
PRIMARY Change From Week 6 to Week 10 in Delay Discounting - MCQ Scores	0.35	—
PRIMARY Change From Week 6 to Week 10 in BIS-11 Total Score	-1.2	—
PRIMARY Change From Week 6 to Week 10 in KSQ Anger-hostility Subscore	1.2	—
PRIMARY Change From Week 6 to Week 10 in KSQ Depression Subscore	2.1	—
PRIMARY Change From Week 6 to Week 10 in CGI-S Score	0.3	—
PRIMARY Change From Baseline to Week 6 in MADRS Total Score in Patients With a Pre-defined Baseline BIS-11 Total Score	-14.41; -15.45	—
PRIMARY Change From Baseline to Week 6 in CGI-S Score in Patients With a Pre-defined Baseline BIS-11 Total Score	-1.31; -1.53	—
PRIMARY CGI-I Score at Week 6 Patients With a Pre-defined Baseline BIS-11 Total Score	2.48; 1.83	—

Summary

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

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

Main inclusion criteria at baseline visit:

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.

Other inclusion and exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01942785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.