A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

Phase 2

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: ALKS 5461
Drug: Placebo

Registration Number: NCT01500200

Lead Sponsor: Alkermes, Inc.

Brief Summary: This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

Detailed Description: The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 142

Inclusion Criteria

Diagnosed with a major depressive episode (MDE)
Body mass index less than or equal to 40 kg/m2
Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to remain stable throughout the study
History of inadequate response during the entire current MDE to 1 or 2 adequate antidepressant treatments, including current treatment
Be otherwise physically healthy

Exclusion Criteria

Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic stress disorder
Have a clinically significant current axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
Are experiencing hallucinations, delusions, or any psychotic symptomatology in the current MDE
Receive new onset psychotherapy within 6 weeks of screening
Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before screening
Have received electroconvulsive therapy during the current MDE
Have attempted suicide within the past 2 years
Have a thyroid pathology
Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin syndrome
Have a positive test for human immunodeficiency virus (HIV)

Additional inclusion/exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS 5461	ALKS 5461	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score	Baseline and 4 weeks for each stage	The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Who Exhibited Treatment Response (HAM-D17)	4 weeks for each stage	The proportion of subjects demonstrating HAM-D17 treatment response, defined as a ≥ 50% reduction in HAM-D17 score from baseline to the end of the efficacy period (Week 4). The HAM-D17 is a clinician administered questionnaire comprised of 17 questions used to assess the severity of a patient's depression. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score	4 weeks for each stage	The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score	4 weeks for each stage	The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.